Non-serious adverse events
|
Arm A: Ublituximab + Umbralisib (TGR-1202) |
Arm B: Umbralisib (TGR-1202) Monotherapy |
Arm C: Ublituximab + Umbralisib (TGR-1202) + Bendamustine |
Arm D: Ublituximab Monotherapy |
Arm E: Ublituximab to Umbralisib (TGR-1202) |
Total subjects affected by non serious adverse events
|
|
|
|
|
|
subjects affected / exposed
|
254 / 262 (96.95%) |
303 / 307 (98.70%) |
125 / 130 (96.15%) |
20 / 24 (83.33%) |
12 / 12 (100.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
|
Basal cell carcinoma
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
6 |
1 |
0 |
1 |
0 |
Lipoma
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
0 |
0 |
Benign neoplasm of eye
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Bowen's disease
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Central nervous system lymphoma
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Haemangioma of skin
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Meningioma
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Neoplasm skin
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Seborrhoeic keratosis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Skin cancer
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Squamous cell carcinoma of head and neck
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
1 |
0 |
0 |
Tumour pain
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
4 / 307 (1.30%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
4 |
4 |
0 |
0 |
Cancer pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
2 |
0 |
0 |
Gastrointestinal tract adenoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Haemangioma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Neoplasm
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Oral neoplasm
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Skin neoplasm bleeding
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
Squamous cell carcinoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
1 |
0 |
Squamous cell carcinoma of skin
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Vascular disorders
|
|
|
|
|
|
Hypertension
|
|
|
|
|
|
subjects affected / exposed
|
20 / 262 (7.63%) |
23 / 307 (7.49%) |
2 / 130 (1.54%) |
3 / 24 (12.50%) |
0 / 12 (0.00%) |
occurrences all number
|
29 |
34 |
2 |
5 |
0 |
Flushing
|
|
|
|
|
|
subjects affected / exposed
|
10 / 262 (3.82%) |
4 / 307 (1.30%) |
2 / 130 (1.54%) |
3 / 24 (12.50%) |
0 / 12 (0.00%) |
occurrences all number
|
11 |
4 |
2 |
3 |
0 |
Hypotension
|
|
|
|
|
|
subjects affected / exposed
|
7 / 262 (2.67%) |
10 / 307 (3.26%) |
13 / 130 (10.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
7 |
12 |
19 |
0 |
0 |
Hot flush
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
18 / 307 (5.86%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
19 |
1 |
0 |
0 |
Deep vein thrombosis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
2 |
2 |
0 |
0 |
Haematoma
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
2 |
2 |
0 |
0 |
1 |
Lymphoedema
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Thrombophlebitis superficial
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
2 |
0 |
0 |
Arterial thrombosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Embolism
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
3 |
1 |
0 |
0 |
Embolism venous
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Hyperaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Pallor
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Peripheral coldness
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Peripheral venous disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Subgaleal haematoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Varicose vein
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Vascular insufficiency
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Vasculitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Surgical and medical procedures
|
|
|
|
|
|
Skin neoplasm excision
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
0 |
0 |
0 |
0 |
Hip arthroplasty
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Tooth extraction
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Cancer surgery
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Cataract operation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Cerumen removal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Knee arthroplasty
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
General disorders and administration site conditions
|
|
|
|
|
|
Fatigue
|
|
|
|
|
|
subjects affected / exposed
|
80 / 262 (30.53%) |
96 / 307 (31.27%) |
49 / 130 (37.69%) |
5 / 24 (20.83%) |
3 / 12 (25.00%) |
occurrences all number
|
109 |
133 |
71 |
5 |
3 |
Oedema peripheral
|
|
|
|
|
|
subjects affected / exposed
|
35 / 262 (13.36%) |
35 / 307 (11.40%) |
15 / 130 (11.54%) |
4 / 24 (16.67%) |
2 / 12 (16.67%) |
occurrences all number
|
43 |
51 |
19 |
5 |
2 |
Pyrexia
|
|
|
|
|
|
subjects affected / exposed
|
32 / 262 (12.21%) |
37 / 307 (12.05%) |
17 / 130 (13.08%) |
3 / 24 (12.50%) |
2 / 12 (16.67%) |
occurrences all number
|
37 |
63 |
29 |
3 |
2 |
Asthenia
|
|
|
|
|
|
subjects affected / exposed
|
25 / 262 (9.54%) |
29 / 307 (9.45%) |
14 / 130 (10.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
30 |
37 |
20 |
0 |
0 |
Chills
|
|
|
|
|
|
subjects affected / exposed
|
23 / 262 (8.78%) |
22 / 307 (7.17%) |
6 / 130 (4.62%) |
2 / 24 (8.33%) |
0 / 12 (0.00%) |
occurrences all number
|
32 |
27 |
6 |
3 |
0 |
Non-cardiac chest pain
|
|
|
|
|
|
subjects affected / exposed
|
9 / 262 (3.44%) |
5 / 307 (1.63%) |
1 / 130 (0.77%) |
2 / 24 (8.33%) |
0 / 12 (0.00%) |
occurrences all number
|
9 |
6 |
1 |
2 |
0 |
Pain
|
|
|
|
|
|
subjects affected / exposed
|
9 / 262 (3.44%) |
7 / 307 (2.28%) |
6 / 130 (4.62%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
9 |
7 |
6 |
0 |
0 |
Chest discomfort
|
|
|
|
|
|
subjects affected / exposed
|
6 / 262 (2.29%) |
3 / 307 (0.98%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
6 |
4 |
3 |
0 |
0 |
Peripheral swelling
|
|
|
|
|
|
subjects affected / exposed
|
6 / 262 (2.29%) |
10 / 307 (3.26%) |
4 / 130 (3.08%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
8 |
11 |
4 |
1 |
0 |
Feeling abnormal
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
5 |
0 |
0 |
0 |
Influenza like illness
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
4 / 307 (1.30%) |
3 / 130 (2.31%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
4 |
3 |
1 |
0 |
Swelling
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
3 |
0 |
0 |
0 |
Catheter site pain
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
2 |
0 |
0 |
0 |
Chest pain
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
8 / 307 (2.61%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
8 |
3 |
0 |
0 |
Face oedema
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
2 |
2 |
0 |
0 |
Feeling hot
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
1 |
0 |
Gait disturbance
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
3 / 307 (0.98%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
3 |
2 |
0 |
0 |
Localised oedema
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
3 |
1 |
0 |
0 |
Malaise
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
7 / 307 (2.28%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
8 |
0 |
0 |
0 |
Swelling face
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Administration site extravasation
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Adverse drug reaction
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Axillary pain
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
1 |
0 |
Catheter site swelling
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Discomfort
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
1 |
0 |
0 |
Early satiety
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
1 |
0 |
0 |
Facial pain
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Feeling jittery
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
1 |
0 |
0 |
Illness
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Injection site bruising
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Mucosal inflammation
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
1 |
0 |
0 |
Oedema
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
1 |
0 |
Performance status decreased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Disease progression
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Drug intolerance
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Exercise tolerance decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Feeling cold
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
General physical health deterioration
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Generalised oedema
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Mass
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Mucosal hyperaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Nodule
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Sensation of foreign body
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Temperature intolerance
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Tenderness
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Thirst
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Tissue infiltration
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Immune system disorders
|
|
|
|
|
|
Hypersensitivity
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
6 |
0 |
2 |
0 |
0 |
Seasonal allergy
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
3 |
0 |
0 |
0 |
Drug hypersensitivity
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
4 |
0 |
0 |
0 |
Hypogammaglobulinaemia
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
2 |
1 |
0 |
0 |
Allergy to animal
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Contrast media allergy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Contrast media reaction
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Immunodeficiency
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Sarcoidosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Reproductive system and breast disorders
|
|
|
|
|
|
Scrotal oedema
|
|
|
|
|
|
subjects affected / exposed [3]
|
2 / 157 (1.27%) |
0 / 168 (0.00%) |
0 / 78 (0.00%) |
0 / 16 (0.00%) |
0 / 8 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Oedema genital
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Pelvic pain
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Vulvovaginal pain
|
|
|
|
|
|
subjects affected / exposed [4]
|
1 / 105 (0.95%) |
0 / 139 (0.00%) |
0 / 52 (0.00%) |
0 / 8 (0.00%) |
0 / 4 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Benign prostatic hyperplasia
|
|
|
|
|
|
subjects affected / exposed [5]
|
0 / 157 (0.00%) |
2 / 168 (1.19%) |
1 / 78 (1.28%) |
0 / 16 (0.00%) |
0 / 8 (0.00%) |
occurrences all number
|
0 |
2 |
1 |
0 |
0 |
Breast discolouration
|
|
|
|
|
|
subjects affected / exposed [6]
|
0 / 105 (0.00%) |
1 / 139 (0.72%) |
0 / 52 (0.00%) |
0 / 8 (0.00%) |
0 / 4 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Breast mass
|
|
|
|
|
|
subjects affected / exposed [7]
|
0 / 105 (0.00%) |
0 / 139 (0.00%) |
1 / 52 (1.92%) |
0 / 8 (0.00%) |
0 / 4 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Breast oedema
|
|
|
|
|
|
subjects affected / exposed [8]
|
0 / 105 (0.00%) |
1 / 139 (0.72%) |
0 / 52 (0.00%) |
0 / 8 (0.00%) |
0 / 4 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Breast pain
|
|
|
|
|
|
subjects affected / exposed [9]
|
0 / 105 (0.00%) |
2 / 139 (1.44%) |
1 / 52 (1.92%) |
0 / 8 (0.00%) |
0 / 4 (0.00%) |
occurrences all number
|
0 |
2 |
1 |
0 |
0 |
Breast swelling
|
|
|
|
|
|
subjects affected / exposed [10]
|
0 / 105 (0.00%) |
1 / 139 (0.72%) |
0 / 52 (0.00%) |
0 / 8 (0.00%) |
0 / 4 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Genital lesion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Genital rash
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Gynaecomastia
|
|
|
|
|
|
subjects affected / exposed [11]
|
0 / 105 (0.00%) |
1 / 139 (0.72%) |
0 / 52 (0.00%) |
0 / 8 (0.00%) |
0 / 4 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Menstruation irregular
|
|
|
|
|
|
subjects affected / exposed [12]
|
0 / 105 (0.00%) |
0 / 139 (0.00%) |
0 / 52 (0.00%) |
0 / 8 (0.00%) |
1 / 4 (25.00%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
Orchitis noninfective
|
|
|
|
|
|
subjects affected / exposed [13]
|
0 / 157 (0.00%) |
1 / 168 (0.60%) |
0 / 78 (0.00%) |
0 / 16 (0.00%) |
0 / 8 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Peyronie's disease
|
|
|
|
|
|
subjects affected / exposed [14]
|
0 / 157 (0.00%) |
0 / 168 (0.00%) |
1 / 78 (1.28%) |
0 / 16 (0.00%) |
0 / 8 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Testicular oedema
|
|
|
|
|
|
subjects affected / exposed [15]
|
0 / 157 (0.00%) |
1 / 168 (0.60%) |
0 / 78 (0.00%) |
0 / 16 (0.00%) |
0 / 8 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Testicular pain
|
|
|
|
|
|
subjects affected / exposed [16]
|
0 / 157 (0.00%) |
1 / 168 (0.60%) |
1 / 78 (1.28%) |
0 / 16 (0.00%) |
0 / 8 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Vaginal haemorrhage
|
|
|
|
|
|
subjects affected / exposed [17]
|
0 / 105 (0.00%) |
0 / 139 (0.00%) |
2 / 52 (3.85%) |
0 / 8 (0.00%) |
0 / 4 (0.00%) |
occurrences all number
|
0 |
0 |
2 |
0 |
0 |
Vulvovaginal dryness
|
|
|
|
|
|
subjects affected / exposed [18]
|
0 / 105 (0.00%) |
0 / 139 (0.00%) |
1 / 52 (1.92%) |
0 / 8 (0.00%) |
0 / 4 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Vulvovaginal pruritus
|
|
|
|
|
|
subjects affected / exposed [19]
|
0 / 105 (0.00%) |
0 / 139 (0.00%) |
1 / 52 (1.92%) |
0 / 8 (0.00%) |
0 / 4 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
|
Dyspnoea
|
|
|
|
|
|
subjects affected / exposed
|
41 / 262 (15.65%) |
33 / 307 (10.75%) |
18 / 130 (13.85%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
48 |
37 |
23 |
1 |
0 |
Cough
|
|
|
|
|
|
subjects affected / exposed
|
32 / 262 (12.21%) |
57 / 307 (18.57%) |
17 / 130 (13.08%) |
5 / 24 (20.83%) |
2 / 12 (16.67%) |
occurrences all number
|
46 |
78 |
26 |
8 |
2 |
Oropharyngeal pain
|
|
|
|
|
|
subjects affected / exposed
|
10 / 262 (3.82%) |
13 / 307 (4.23%) |
5 / 130 (3.85%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
10 |
13 |
5 |
1 |
0 |
Pleural effusion
|
|
|
|
|
|
subjects affected / exposed
|
7 / 262 (2.67%) |
11 / 307 (3.58%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
7 |
13 |
17 |
0 |
0 |
Productive cough
|
|
|
|
|
|
subjects affected / exposed
|
7 / 262 (2.67%) |
9 / 307 (2.93%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
8 |
11 |
2 |
0 |
0 |
Dysphonia
|
|
|
|
|
|
subjects affected / exposed
|
6 / 262 (2.29%) |
4 / 307 (1.30%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
6 |
4 |
1 |
0 |
0 |
Nasal congestion
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
9 / 307 (2.93%) |
3 / 130 (2.31%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
11 |
3 |
2 |
0 |
Chronic obstructive pulmonary disease
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
0 / 307 (0.00%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
0 |
3 |
0 |
0 |
Epistaxis
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
7 / 307 (2.28%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
7 |
7 |
3 |
0 |
0 |
Hypoxia
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
6 / 307 (1.95%) |
2 / 130 (1.54%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
6 |
2 |
1 |
0 |
Pulmonary oedema
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
1 |
0 |
0 |
0 |
Respiratory tract congestion
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
0 |
0 |
Rhinitis allergic
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
4 / 307 (1.30%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
5 |
3 |
0 |
0 |
Upper-airway cough syndrome
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
5 / 307 (1.63%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
5 |
2 |
0 |
0 |
Wheezing
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
4 / 307 (1.30%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
4 |
0 |
2 |
0 |
Dyspnoea exertional
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
6 / 307 (1.95%) |
4 / 130 (3.08%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
6 |
6 |
1 |
0 |
Haemoptysis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
3 |
1 |
0 |
0 |
Hiccups
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
0 |
0 |
Rhinorrhoea
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
5 / 307 (1.63%) |
4 / 130 (3.08%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
5 |
5 |
0 |
0 |
Throat irritation
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
1 |
0 |
0 |
Atelectasis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Dry throat
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
1 |
0 |
0 |
Interstitial lung disease
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
4 |
0 |
0 |
0 |
Nasal obstruction
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
0 |
0 |
Nasal pruritus
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Nasal ulcer
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Oropharyngeal swelling
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Paranasal sinus discomfort
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Pleurisy
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Pneumonitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
5 / 307 (1.63%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
5 |
1 |
0 |
0 |
Pulmonary embolism
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
2 |
0 |
Pulmonary hypertension
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Pulmonary mass
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Rales
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
4 |
0 |
0 |
0 |
Sinus congestion
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
7 / 307 (2.28%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
7 |
1 |
0 |
0 |
Sinus pain
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
1 |
0 |
Sleep apnoea syndrome
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
0 |
0 |
Throat tightness
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Acute respiratory failure
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
1 |
0 |
0 |
Aspiration
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
Asthma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Bronchial hyperreactivity
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Bronchial obstruction
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Catarrh
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Laryngeal inflammation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Mediastinal shift
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Nasal dryness
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Nasal mucosal ulcer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Nasal oedema
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Nasal polyps
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Nasal septum disorder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Paranasal sinus hypersecretion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Pharyngeal erythema
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Pharyngeal hypertrophy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Pleuritic pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Pneumothorax
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
1 |
0 |
0 |
Respiration abnormal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
Respiratory failure
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Respiratory tract inflammation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Rhinalgia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Rhonchi
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Snoring
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Sputum increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Vasomotor rhinitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Psychiatric disorders
|
|
|
|
|
|
Insomnia
|
|
|
|
|
|
subjects affected / exposed
|
28 / 262 (10.69%) |
40 / 307 (13.03%) |
19 / 130 (14.62%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
33 |
45 |
25 |
1 |
0 |
Anxiety
|
|
|
|
|
|
subjects affected / exposed
|
14 / 262 (5.34%) |
8 / 307 (2.61%) |
7 / 130 (5.38%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
15 |
9 |
7 |
1 |
0 |
Agitation
|
|
|
|
|
|
subjects affected / exposed
|
6 / 262 (2.29%) |
2 / 307 (0.65%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
6 |
2 |
2 |
0 |
0 |
Confusional state
|
|
|
|
|
|
subjects affected / exposed
|
6 / 262 (2.29%) |
16 / 307 (5.21%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
6 |
16 |
1 |
0 |
0 |
Depression
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
13 / 307 (4.23%) |
4 / 130 (3.08%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
5 |
13 |
4 |
0 |
1 |
Restlessness
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
2 |
0 |
0 |
Sleep disorder
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
0 |
0 |
Delirium
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Depressed mood
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
4 |
0 |
0 |
0 |
Euphoric mood
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Irritability
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Mood swings
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Nightmare
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
1 |
0 |
0 |
Poor quality sleep
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Abnormal dreams
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Affect lability
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Bruxism
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Disorientation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Emotional disorder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Hallucination
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Mania
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Mental status changes
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
1 |
0 |
0 |
Mood altered
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Nervousness
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Panic attack
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Self-induced vomiting
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
0 |
0 |
Product issues
|
|
|
|
|
|
Device leakage
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Device breakage
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Device occlusion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
2 |
0 |
0 |
Thrombosis in device
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
Hepatobiliary disorders
|
|
|
|
|
|
Cholecystitis acute
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Hepatic necrosis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Hepatitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Hepatocellular injury
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
0 |
0 |
Bile duct obstruction
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Cholecystitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Gallbladder polyp
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Hepatic cirrhosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Hepatic steatosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Hepatitis acute
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Hyperbilirubinaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Liver disorder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Investigations
|
|
|
|
|
|
Aspartate aminotransferase increased
|
|
|
|
|
|
subjects affected / exposed
|
40 / 262 (15.27%) |
51 / 307 (16.61%) |
14 / 130 (10.77%) |
1 / 24 (4.17%) |
1 / 12 (8.33%) |
occurrences all number
|
80 |
81 |
23 |
1 |
4 |
Alanine aminotransferase increased
|
|
|
|
|
|
subjects affected / exposed
|
38 / 262 (14.50%) |
53 / 307 (17.26%) |
13 / 130 (10.00%) |
1 / 24 (4.17%) |
1 / 12 (8.33%) |
occurrences all number
|
96 |
107 |
20 |
1 |
7 |
Neutrophil count decreased
|
|
|
|
|
|
subjects affected / exposed
|
23 / 262 (8.78%) |
21 / 307 (6.84%) |
17 / 130 (13.08%) |
1 / 24 (4.17%) |
2 / 12 (16.67%) |
occurrences all number
|
76 |
33 |
31 |
2 |
6 |
Blood creatinine increased
|
|
|
|
|
|
subjects affected / exposed
|
17 / 262 (6.49%) |
38 / 307 (12.38%) |
5 / 130 (3.85%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
29 |
52 |
6 |
0 |
1 |
Blood lactate dehydrogenase increased
|
|
|
|
|
|
subjects affected / exposed
|
14 / 262 (5.34%) |
5 / 307 (1.63%) |
6 / 130 (4.62%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
14 |
5 |
7 |
0 |
0 |
Blood alkaline phosphatase increased
|
|
|
|
|
|
subjects affected / exposed
|
12 / 262 (4.58%) |
14 / 307 (4.56%) |
9 / 130 (6.92%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
14 |
20 |
14 |
0 |
0 |
Weight decreased
|
|
|
|
|
|
subjects affected / exposed
|
12 / 262 (4.58%) |
24 / 307 (7.82%) |
14 / 130 (10.77%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
15 |
32 |
19 |
1 |
0 |
Blood bilirubin increased
|
|
|
|
|
|
subjects affected / exposed
|
9 / 262 (3.44%) |
8 / 307 (2.61%) |
5 / 130 (3.85%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
16 |
14 |
9 |
0 |
0 |
Platelet count decreased
|
|
|
|
|
|
subjects affected / exposed
|
9 / 262 (3.44%) |
16 / 307 (5.21%) |
12 / 130 (9.23%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
17 |
28 |
27 |
1 |
0 |
White blood cell count decreased
|
|
|
|
|
|
subjects affected / exposed
|
9 / 262 (3.44%) |
7 / 307 (2.28%) |
9 / 130 (6.92%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
16 |
10 |
25 |
0 |
0 |
Weight increased
|
|
|
|
|
|
subjects affected / exposed
|
7 / 262 (2.67%) |
5 / 307 (1.63%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
7 |
9 |
7 |
0 |
0 |
Lymphocyte count decreased
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
6 / 307 (1.95%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
9 |
8 |
5 |
0 |
0 |
Blood magnesium decreased
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
1 |
0 |
0 |
0 |
Blood pressure increased
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
4 / 307 (1.30%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
5 |
3 |
0 |
0 |
C-reactive protein increased
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
2 |
0 |
0 |
0 |
Hepatic enzyme increased
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
0 |
0 |
1 |
0 |
Blood uric acid increased
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
4 / 307 (1.30%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
4 |
0 |
0 |
0 |
Ejection fraction decreased
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
1 |
0 |
0 |
Gamma-glutamyltransferase increased
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
2 |
0 |
0 |
0 |
Glomerular filtration rate
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
1 |
0 |
0 |
Ammonia increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Blood albumin decreased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Blood bicarbonate decreased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Blood calcium increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Blood cholesterol increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
3 |
1 |
0 |
0 |
Blood glucose increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Blood immunoglobulin G decreased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Blood urea increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Blood urine present
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Cardiac murmur
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
3 |
1 |
0 |
0 |
Clostridium test positive
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Coronavirus test positive
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Cytomegalovirus test positive
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
ECG signs of myocardial ischaemia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Electrocardiogram QT prolonged
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Haemoglobin decreased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Hepatic enzyme abnormal
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Immunoglobulins decreased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Liver function test increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Magnetic resonance imaging brain abnormal
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Prostatic specific antigen increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Prothrombin time prolonged
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Red blood cell sedimentation rate increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Transaminases increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
4 |
1 |
0 |
0 |
Troponin increased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Urinary sediment present
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Vitamin B12 decreased
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Beta globulin decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Blood creatine phosphokinase increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
2 |
0 |
0 |
Blood immunoglobulin A decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Blood immunoglobulin M increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Blood iron decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Blood potassium decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Blood prolactin increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Blood testosterone decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Blood viscosity increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Body temperature decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
4 |
0 |
0 |
0 |
Body temperature increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Bone density decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Breath sounds abnormal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Eastern Cooperative Oncology Group performance status worsened
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Faecal calprotectin increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Haemoglobin increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Haemophilus test positive
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Heart rate increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Human rhinovirus positive
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Immature granulocyte count increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Immunoglobulins increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
International normalised ratio increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
4 / 307 (1.30%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
7 |
0 |
0 |
0 |
Light chain analysis decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Light chain analysis increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Lipase increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
3 |
0 |
0 |
Low density lipoprotein increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Lymphocyte count abnormal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Lymphocyte count increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
0 |
0 |
Monocyte count decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Neutrophil count increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Pedal pulse decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Platelet count increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Protein total decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Protein urine present
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Red cell distribution width increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
SARS-CoV-2 test positive
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
0 |
2 |
0 |
0 |
1 |
Serum ferritin decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Troponin I increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Vitamin D decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
2 |
0 |
0 |
White blood cell count increased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Injury, poisoning and procedural complications
|
|
|
|
|
|
Infusion related reaction
|
|
|
|
|
|
subjects affected / exposed
|
30 / 262 (11.45%) |
2 / 307 (0.65%) |
4 / 130 (3.08%) |
3 / 24 (12.50%) |
0 / 12 (0.00%) |
occurrences all number
|
35 |
2 |
5 |
5 |
0 |
Fall
|
|
|
|
|
|
subjects affected / exposed
|
15 / 262 (5.73%) |
17 / 307 (5.54%) |
11 / 130 (8.46%) |
1 / 24 (4.17%) |
1 / 12 (8.33%) |
occurrences all number
|
16 |
19 |
12 |
1 |
1 |
Skin laceration
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
0 / 307 (0.00%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
0 |
2 |
0 |
0 |
Limb injury
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Procedural pain
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
0 |
0 |
Accidental overdose
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Arthropod bite
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
1 / 12 (8.33%) |
occurrences all number
|
1 |
3 |
0 |
1 |
1 |
Arthropod sting
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Lumbar vertebral fracture
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Radius fracture
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Rib fracture
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Skin abrasion
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
2 |
0 |
0 |
Thoracic vertebral fracture
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Traumatic intracranial haematoma
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Wound secretion
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Ankle fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Compression fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Concussion
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
Foreign body in ear
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Hand fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Head injury
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Hip fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
2 |
0 |
0 |
Joint injury
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Lip injury
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Meniscus injury
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Muscle strain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Overdose
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Periorbital haematoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Procedural hypotension
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Product administration error
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Skin injury
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
Spinal compression fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Spinal fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Splenic injury
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Stress fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Subdural haematoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Tendon rupture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Thermal burn
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Tibia fracture
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Wound complication
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Congenital, familial and genetic disorders
|
|
|
|
|
|
Phimosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Cardiac disorders
|
|
|
|
|
|
Tachycardia
|
|
|
|
|
|
subjects affected / exposed
|
9 / 262 (3.44%) |
8 / 307 (2.61%) |
7 / 130 (5.38%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
10 |
8 |
7 |
0 |
0 |
Atrial fibrillation
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
5 / 307 (1.63%) |
5 / 130 (3.85%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
7 |
6 |
5 |
0 |
0 |
Palpitations
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
4 / 307 (1.30%) |
5 / 130 (3.85%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
9 |
4 |
5 |
0 |
0 |
Angina pectoris
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
3 |
0 |
0 |
0 |
Cardiac failure
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Pericardial effusion
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
3 |
1 |
0 |
0 |
Sinus tachycardia
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
5 / 307 (1.63%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
6 |
2 |
0 |
0 |
Atrial tachycardia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Atrioventricular block complete
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Atrioventricular block second degree
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Cardiac failure congestive
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Cardiomyopathy
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Coronary artery disease
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Sinus bradycardia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Ventricular extrasystoles
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Aortic valve incompetence
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Arrhythmia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
2 |
0 |
0 |
Bradycardia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Cardiovascular insufficiency
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Extrasystoles
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Mitral valve incompetence
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Pericarditis constrictive
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Supraventricular tachycardia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Nervous system disorders
|
|
|
|
|
|
Headache
|
|
|
|
|
|
subjects affected / exposed
|
49 / 262 (18.70%) |
50 / 307 (16.29%) |
15 / 130 (11.54%) |
2 / 24 (8.33%) |
0 / 12 (0.00%) |
occurrences all number
|
67 |
81 |
18 |
2 |
0 |
Dizziness
|
|
|
|
|
|
subjects affected / exposed
|
44 / 262 (16.79%) |
51 / 307 (16.61%) |
16 / 130 (12.31%) |
4 / 24 (16.67%) |
3 / 12 (25.00%) |
occurrences all number
|
50 |
63 |
21 |
4 |
3 |
Dysgeusia
|
|
|
|
|
|
subjects affected / exposed
|
19 / 262 (7.25%) |
27 / 307 (8.79%) |
8 / 130 (6.15%) |
1 / 24 (4.17%) |
1 / 12 (8.33%) |
occurrences all number
|
19 |
29 |
10 |
1 |
1 |
Paraesthesia
|
|
|
|
|
|
subjects affected / exposed
|
14 / 262 (5.34%) |
10 / 307 (3.26%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
20 |
15 |
0 |
0 |
0 |
Tremor
|
|
|
|
|
|
subjects affected / exposed
|
13 / 262 (4.96%) |
14 / 307 (4.56%) |
9 / 130 (6.92%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
15 |
16 |
16 |
0 |
1 |
Neuropathy peripheral
|
|
|
|
|
|
subjects affected / exposed
|
7 / 262 (2.67%) |
7 / 307 (2.28%) |
3 / 130 (2.31%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
7 |
7 |
3 |
1 |
0 |
Somnolence
|
|
|
|
|
|
subjects affected / exposed
|
6 / 262 (2.29%) |
8 / 307 (2.61%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
6 |
10 |
1 |
0 |
0 |
Memory impairment
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
7 / 307 (2.28%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
8 |
2 |
0 |
0 |
Peripheral sensory neuropathy
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
6 / 307 (1.95%) |
6 / 130 (4.62%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
6 |
8 |
1 |
0 |
Syncope
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
5 / 307 (1.63%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
5 |
4 |
0 |
0 |
Dysarthria
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Dyskinesia
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
0 |
0 |
Hypoaesthesia
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
3 |
1 |
0 |
0 |
Lethargy
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
2 |
2 |
0 |
0 |
Taste disorder
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
7 / 307 (2.28%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
7 |
2 |
0 |
0 |
Amnesia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
5 / 307 (1.63%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
6 |
1 |
0 |
0 |
Aphasia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Balance disorder
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
3 |
0 |
0 |
Burning feet syndrome
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Carotid artery dissection
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Disturbance in attention
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
1 |
0 |
Dizziness postural
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Extrapyramidal disorder
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Facial paralysis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Loss of consciousness
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Muscle contractions involuntary
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Neuralgia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
5 |
1 |
0 |
0 |
Notalgia paraesthetica
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Presyncope
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
1 |
0 |
0 |
Restless legs syndrome
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Seizure
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Ageusia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Anosmia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Burning sensation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Carpal tunnel syndrome
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Cervical radiculopathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
1 |
0 |
0 |
Cognitive disorder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
0 |
2 |
1 |
0 |
1 |
Coordination abnormal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Depressed level of consciousness
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Encephalopathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
0 |
1 |
0 |
Haemorrhage intracranial
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Head discomfort
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Hemiparesis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Hypogeusia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Intracranial aneurysm
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Lumbar radiculopathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Metabolic encephalopathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Nerve compression
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Parosmia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Peripheral motor neuropathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Polyneuropathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Post herpetic neuralgia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
2 |
0 |
0 |
Psychomotor hyperactivity
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Sciatica
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
4 |
0 |
0 |
0 |
Sensory loss
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Sinus headache
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Spinal cord compression
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Trigeminal neuralgia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Vascular headache
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Blood and lymphatic system disorders
|
|
|
|
|
|
Neutropenia
|
|
|
|
|
|
subjects affected / exposed
|
48 / 262 (18.32%) |
28 / 307 (9.12%) |
42 / 130 (32.31%) |
3 / 24 (12.50%) |
3 / 12 (25.00%) |
occurrences all number
|
88 |
70 |
113 |
4 |
7 |
Anaemia
|
|
|
|
|
|
subjects affected / exposed
|
33 / 262 (12.60%) |
33 / 307 (10.75%) |
30 / 130 (23.08%) |
1 / 24 (4.17%) |
2 / 12 (16.67%) |
occurrences all number
|
46 |
59 |
71 |
2 |
6 |
Thrombocytopenia
|
|
|
|
|
|
subjects affected / exposed
|
9 / 262 (3.44%) |
16 / 307 (5.21%) |
17 / 130 (13.08%) |
1 / 24 (4.17%) |
4 / 12 (33.33%) |
occurrences all number
|
24 |
39 |
39 |
1 |
5 |
Lymph node pain
|
|
|
|
|
|
subjects affected / exposed
|
6 / 262 (2.29%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
1 / 12 (8.33%) |
occurrences all number
|
6 |
1 |
0 |
1 |
1 |
Lymphopenia
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
0 / 307 (0.00%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
0 |
3 |
0 |
0 |
Leukopenia
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
6 / 307 (1.95%) |
9 / 130 (6.92%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
10 |
24 |
1 |
0 |
Febrile neutropenia
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
2 |
0 |
0 |
Lymphadenopathy
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
4 / 130 (3.08%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
4 |
1 |
0 |
Haemorrhagic diathesis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Normochromic anaemia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Blood loss anaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
2 |
0 |
0 |
Bone marrow failure
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
Eosinophilia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Iron deficiency anaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
0 |
1 |
2 |
0 |
1 |
Leukocytosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
3 |
1 |
0 |
0 |
Lymphocytosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
4 / 307 (1.30%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
8 |
0 |
0 |
0 |
Macrocytosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Microcytic anaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Pancytopenia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Paratracheal lymphadenopathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Splenic infarction
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Ear and labyrinth disorders
|
|
|
|
|
|
Tinnitus
|
|
|
|
|
|
subjects affected / exposed
|
7 / 262 (2.67%) |
9 / 307 (2.93%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
7 |
10 |
2 |
0 |
0 |
Ear pain
|
|
|
|
|
|
subjects affected / exposed
|
6 / 262 (2.29%) |
5 / 307 (1.63%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
7 |
5 |
1 |
0 |
0 |
Vertigo
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
1 |
1 |
0 |
0 |
Deafness
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
0 |
0 |
Ear congestion
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
1 |
0 |
0 |
Ear pruritus
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Ear swelling
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
External ear inflammation
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Hypoacusis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
3 |
1 |
0 |
0 |
Otorrhoea
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Vertigo positional
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Deafness unilateral
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Ear discomfort
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Ear disorder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Excessive cerumen production
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Presbyacusis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Eye disorders
|
|
|
|
|
|
Vision blurred
|
|
|
|
|
|
subjects affected / exposed
|
14 / 262 (5.34%) |
12 / 307 (3.91%) |
4 / 130 (3.08%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
15 |
15 |
5 |
0 |
0 |
Dry eye
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
6 |
0 |
0 |
0 |
1 |
Diplopia
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
0 |
0 |
Lacrimation increased
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
5 / 307 (1.63%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
6 |
1 |
0 |
0 |
Eyelid ptosis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
1 |
0 |
0 |
0 |
Vitreous floaters
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
2 |
1 |
0 |
0 |
Cataract
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
1 |
0 |
0 |
Conjunctival haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
1 |
0 |
0 |
Conjunctival hyperaemia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Conjunctival oedema
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Erythema of eyelid
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Eye discharge
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Eye disorder
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Eye inflammation
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Eye pain
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
2 |
0 |
0 |
Eye pruritus
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Eyelid oedema
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Ocular discomfort
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Periorbital oedema
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
1 |
0 |
0 |
Retinal haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Visual acuity reduced
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
0 |
0 |
Asthenopia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Blepharitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Conjunctivitis allergic
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Eye haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Eye irritation
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Eye swelling
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Glaucoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Hypermetropia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Mydriasis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Ocular hyperaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Photopsia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Retinal detachment
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Retinal tear
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Scleral hyperaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Visual impairment
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
3 / 307 (0.98%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
3 |
4 |
0 |
0 |
Xerophthalmia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Gastrointestinal disorders
|
|
|
|
|
|
Diarrhoea
|
|
|
|
|
|
subjects affected / exposed
|
114 / 262 (43.51%) |
163 / 307 (53.09%) |
62 / 130 (47.69%) |
3 / 24 (12.50%) |
7 / 12 (58.33%) |
occurrences all number
|
252 |
372 |
96 |
5 |
16 |
Nausea
|
|
|
|
|
|
subjects affected / exposed
|
104 / 262 (39.69%) |
120 / 307 (39.09%) |
56 / 130 (43.08%) |
2 / 24 (8.33%) |
4 / 12 (33.33%) |
occurrences all number
|
144 |
177 |
79 |
3 |
4 |
Vomiting
|
|
|
|
|
|
subjects affected / exposed
|
39 / 262 (14.89%) |
65 / 307 (21.17%) |
35 / 130 (26.92%) |
1 / 24 (4.17%) |
3 / 12 (25.00%) |
occurrences all number
|
58 |
86 |
56 |
1 |
3 |
Constipation
|
|
|
|
|
|
subjects affected / exposed
|
30 / 262 (11.45%) |
29 / 307 (9.45%) |
19 / 130 (14.62%) |
1 / 24 (4.17%) |
1 / 12 (8.33%) |
occurrences all number
|
32 |
37 |
21 |
1 |
1 |
Abdominal pain
|
|
|
|
|
|
subjects affected / exposed
|
28 / 262 (10.69%) |
37 / 307 (12.05%) |
17 / 130 (13.08%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
37 |
51 |
18 |
1 |
0 |
Gastrooesophageal reflux disease
|
|
|
|
|
|
subjects affected / exposed
|
17 / 262 (6.49%) |
15 / 307 (4.89%) |
4 / 130 (3.08%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
17 |
16 |
4 |
0 |
1 |
Dyspepsia
|
|
|
|
|
|
subjects affected / exposed
|
12 / 262 (4.58%) |
26 / 307 (8.47%) |
15 / 130 (11.54%) |
2 / 24 (8.33%) |
0 / 12 (0.00%) |
occurrences all number
|
12 |
30 |
18 |
2 |
0 |
Abdominal pain upper
|
|
|
|
|
|
subjects affected / exposed
|
10 / 262 (3.82%) |
18 / 307 (5.86%) |
1 / 130 (0.77%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
11 |
30 |
1 |
1 |
0 |
Colitis
|
|
|
|
|
|
subjects affected / exposed
|
10 / 262 (3.82%) |
5 / 307 (1.63%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
14 |
6 |
1 |
0 |
0 |
Abdominal distension
|
|
|
|
|
|
subjects affected / exposed
|
9 / 262 (3.44%) |
20 / 307 (6.51%) |
7 / 130 (5.38%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
10 |
21 |
8 |
1 |
0 |
Abdominal discomfort
|
|
|
|
|
|
subjects affected / exposed
|
8 / 262 (3.05%) |
7 / 307 (2.28%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
9 |
7 |
3 |
0 |
0 |
Flatulence
|
|
|
|
|
|
subjects affected / exposed
|
8 / 262 (3.05%) |
14 / 307 (4.56%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
9 |
15 |
3 |
0 |
0 |
Dry mouth
|
|
|
|
|
|
subjects affected / exposed
|
6 / 262 (2.29%) |
5 / 307 (1.63%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
6 |
5 |
1 |
0 |
0 |
Dysphagia
|
|
|
|
|
|
subjects affected / exposed
|
6 / 262 (2.29%) |
7 / 307 (2.28%) |
5 / 130 (3.85%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
7 |
8 |
5 |
0 |
0 |
Stomatitis
|
|
|
|
|
|
subjects affected / exposed
|
6 / 262 (2.29%) |
15 / 307 (4.89%) |
7 / 130 (5.38%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
7 |
16 |
9 |
0 |
0 |
Anal incontinence
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
2 |
0 |
0 |
0 |
Haemorrhoids
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
5 |
2 |
2 |
0 |
1 |
Inguinal hernia
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
2 |
0 |
0 |
0 |
Oral pain
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
6 / 307 (1.95%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
7 |
2 |
0 |
0 |
Abdominal pain lower
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
4 |
1 |
0 |
0 |
Ascites
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
2 / 307 (0.65%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
2 |
3 |
0 |
0 |
Gastritis
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
3 |
0 |
0 |
0 |
Toothache
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
4 / 307 (1.30%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
4 |
0 |
0 |
0 |
Eructation
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
0 |
0 |
Haemorrhoidal haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
2 |
2 |
0 |
0 |
Mouth ulceration
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
3 |
0 |
0 |
Proctalgia
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
1 |
0 |
0 |
Salivary hypersecretion
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Abdominal hernia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Abdominal rigidity
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Anal polyp
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Barrett's oesophagus
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
1 |
0 |
0 |
Chapped lips
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Diverticulum
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Duodenitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Enterocolitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
0 |
0 |
Epigastric discomfort
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
3 |
0 |
0 |
Faeces discoloured
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Gastrointestinal pain
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
1 |
0 |
0 |
Gastrointestinal sounds abnormal
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Haematochezia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
1 |
0 |
0 |
Hiatus hernia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
0 |
0 |
Large intestine polyp
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Leukoplakia oral
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Lip blister
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Mouth haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Oesophagitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Oral dysaesthesia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Oral mucosal eruption
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Pancreatitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Parotid gland enlargement
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Proctitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Rectal haemorrhage
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Salivary gland pain
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Tongue coated
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Tongue disorder
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Umbilical hernia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Abdominal adhesions
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Abdominal mass
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Abdominal tenderness
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Abnormal faeces
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Aphthous ulcer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Apical granuloma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Autoimmune enteropathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Breath odour
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Chronic gastritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
0 |
2 |
0 |
0 |
1 |
Colitis microscopic
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Defaecation urgency
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Diverticulum intestinal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
0 |
0 |
Faecal vomiting
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Faeces soft
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
0 |
0 |
0 |
0 |
1 |
Frequent bowel movements
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Gastric disorder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Gastric mucosa erythema
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Gastric ulcer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Gastritis haemorrhagic
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Gastrooesophageal sphincter insufficiency
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Gingival bleeding
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
0 |
1 |
0 |
0 |
1 |
Gingival pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Haematemesis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Hypoaesthesia oral
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Ileus
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Impaired gastric emptying
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
0 |
1 |
0 |
0 |
1 |
Intra-abdominal haematoma
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Irritable bowel syndrome
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Large intestinal ulcer
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Lip exfoliation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Melaena
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Mesenteric vein thrombosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Neutropenic colitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
4 |
0 |
0 |
Odynophagia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Oedematous pancreatitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Oesophageal stenosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Oral disorder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Oral mucosal blistering
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Palatal disorder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Pancreatitis acute
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Paraesthesia oral
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
4 |
0 |
0 |
0 |
Periodontal disease
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Poor dental condition
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Reflux gastritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Stomatitis necrotising
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Tongue ulceration
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
4 |
0 |
0 |
0 |
Varices oesophageal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
|
Rash
|
|
|
|
|
|
subjects affected / exposed
|
23 / 262 (8.78%) |
27 / 307 (8.79%) |
16 / 130 (12.31%) |
3 / 24 (12.50%) |
3 / 12 (25.00%) |
occurrences all number
|
24 |
30 |
21 |
3 |
6 |
Pruritus
|
|
|
|
|
|
subjects affected / exposed
|
20 / 262 (7.63%) |
14 / 307 (4.56%) |
12 / 130 (9.23%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
24 |
19 |
16 |
1 |
0 |
Erythema
|
|
|
|
|
|
subjects affected / exposed
|
9 / 262 (3.44%) |
8 / 307 (2.61%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
15 |
12 |
3 |
0 |
0 |
Alopecia
|
|
|
|
|
|
subjects affected / exposed
|
8 / 262 (3.05%) |
10 / 307 (3.26%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
8 |
10 |
0 |
1 |
0 |
Hyperhidrosis
|
|
|
|
|
|
subjects affected / exposed
|
8 / 262 (3.05%) |
13 / 307 (4.23%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
8 |
14 |
2 |
0 |
0 |
Night sweats
|
|
|
|
|
|
subjects affected / exposed
|
8 / 262 (3.05%) |
22 / 307 (7.17%) |
5 / 130 (3.85%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
9 |
25 |
5 |
1 |
0 |
Rash maculo-papular
|
|
|
|
|
|
subjects affected / exposed
|
8 / 262 (3.05%) |
11 / 307 (3.58%) |
9 / 130 (6.92%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
12 |
13 |
13 |
1 |
0 |
Dry skin
|
|
|
|
|
|
subjects affected / exposed
|
7 / 262 (2.67%) |
10 / 307 (3.26%) |
5 / 130 (3.85%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
8 |
11 |
6 |
0 |
0 |
Rash pruritic
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
2 / 307 (0.65%) |
4 / 130 (3.08%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
7 |
2 |
4 |
0 |
0 |
Skin mass
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
3 |
0 |
0 |
0 |
Ecchymosis
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
0 |
1 |
0 |
0 |
Skin ulcer
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
2 / 307 (0.65%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
3 |
2 |
0 |
0 |
Actinic keratosis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
1 |
0 |
0 |
Dermatitis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
0 |
0 |
Pain of skin
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
1 |
0 |
0 |
Urticaria
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
4 |
0 |
1 |
0 |
Angioedema
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Blister
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Decubitus ulcer
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Dermatitis atopic
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Eczema asteatotic
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Exfoliative rash
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Hyperkeratosis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Hypersensitivity vasculitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Onychoclasis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Psoriasis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
8 |
0 |
1 |
0 |
Purpura
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Rash macular
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Rosacea
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Skin burning sensation
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Skin discolouration
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
2 |
0 |
0 |
Skin fissures
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Skin irritation
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
0 |
0 |
0 |
0 |
Skin lesion
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
2 |
0 |
0 |
Skin tightness
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Stasis dermatitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Cold sweat
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Dermal cyst
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Dermatitis acneiform
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Dermatitis bullous
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Dermatitis exfoliative generalised
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
0 |
0 |
Drug eruption
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Eczema
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
4 / 307 (1.30%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
7 |
0 |
0 |
0 |
Erythema multiforme
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Nail discolouration
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Palmar-plantar erythrodysaesthesia syndrome
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Papule
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Photosensitivity reaction
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Purpura senile
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Rash erythematous
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Scab
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Scar pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Skin atrophy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Skin discomfort
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Skin exfoliation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
4 / 307 (1.30%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
6 |
0 |
0 |
0 |
Skin hypopigmentation
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Skin necrosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Skin plaque
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Skin reaction
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Telangiectasia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Renal and urinary disorders
|
|
|
|
|
|
Pollakiuria
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
5 / 307 (1.63%) |
4 / 130 (3.08%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
5 |
4 |
0 |
0 |
Acute kidney injury
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
3 / 307 (0.98%) |
7 / 130 (5.38%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
6 |
3 |
9 |
0 |
0 |
Haematuria
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
5 |
3 |
1 |
0 |
1 |
Dysuria
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
0 / 307 (0.00%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
0 |
2 |
0 |
0 |
Chronic kidney disease
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
3 |
1 |
0 |
0 |
Proteinuria
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
0 |
0 |
Calculus urinary
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Micturition urgency
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
1 |
0 |
0 |
Polyuria
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
0 |
0 |
Renal failure
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Strangury
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Ureteric stenosis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Urinary hesitation
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Urinary retention
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
2 |
0 |
0 |
Urinary tract obstruction
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Urine odour abnormal
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Azotaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Bladder discomfort
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Haemorrhage urinary tract
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Hydronephrosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Hypertonic bladder
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Nephrolithiasis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
1 |
0 |
0 |
Nephropathy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
0 |
0 |
Nocturia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Renal pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Ureterolithiasis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Urinary incontinence
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
4 / 307 (1.30%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
5 |
1 |
0 |
0 |
Urinary tract pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Endocrine disorders
|
|
|
|
|
|
Hypothyroidism
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Adrenal insufficiency
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Hyperparathyroidism
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Hypercalcaemia of malignancy
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Hyperthyroidism
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
0 |
0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
|
Back pain
|
|
|
|
|
|
subjects affected / exposed
|
32 / 262 (12.21%) |
32 / 307 (10.42%) |
11 / 130 (8.46%) |
4 / 24 (16.67%) |
1 / 12 (8.33%) |
occurrences all number
|
42 |
42 |
14 |
6 |
1 |
Arthralgia
|
|
|
|
|
|
subjects affected / exposed
|
21 / 262 (8.02%) |
34 / 307 (11.07%) |
17 / 130 (13.08%) |
3 / 24 (12.50%) |
0 / 12 (0.00%) |
occurrences all number
|
48 |
47 |
18 |
3 |
0 |
Pain in extremity
|
|
|
|
|
|
subjects affected / exposed
|
12 / 262 (4.58%) |
25 / 307 (8.14%) |
9 / 130 (6.92%) |
3 / 24 (12.50%) |
1 / 12 (8.33%) |
occurrences all number
|
12 |
32 |
10 |
4 |
1 |
Muscle spasms
|
|
|
|
|
|
subjects affected / exposed
|
9 / 262 (3.44%) |
19 / 307 (6.19%) |
8 / 130 (6.15%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
14 |
23 |
8 |
1 |
0 |
Muscular weakness
|
|
|
|
|
|
subjects affected / exposed
|
8 / 262 (3.05%) |
16 / 307 (5.21%) |
8 / 130 (6.15%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
8 |
20 |
9 |
1 |
0 |
Flank pain
|
|
|
|
|
|
subjects affected / exposed
|
6 / 262 (2.29%) |
11 / 307 (3.58%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
8 |
12 |
2 |
0 |
0 |
Groin pain
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
10 / 307 (3.26%) |
3 / 130 (2.31%) |
2 / 24 (8.33%) |
1 / 12 (8.33%) |
occurrences all number
|
5 |
10 |
3 |
2 |
1 |
Musculoskeletal pain
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
13 / 307 (4.23%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
19 |
4 |
0 |
0 |
Joint swelling
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
2 |
0 |
0 |
0 |
Bone pain
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
4 / 307 (1.30%) |
8 / 130 (6.15%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
7 |
8 |
1 |
0 |
Musculoskeletal discomfort
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
1 |
0 |
0 |
0 |
Arthritis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
3 / 307 (0.98%) |
1 / 130 (0.77%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
4 |
1 |
1 |
0 |
Muscle tightness
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
0 |
0 |
Musculoskeletal chest pain
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
4 / 307 (1.30%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
5 |
2 |
0 |
0 |
Osteoporosis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Pain in jaw
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
3 |
0 |
0 |
0 |
Axillary mass
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Intervertebral disc protrusion
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Joint stiffness
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
1 |
0 |
0 |
0 |
1 |
Osteoarthritis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
1 |
0 |
0 |
Periarthritis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Psoriatic arthropathy
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Rheumatoid arthritis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Rotator cuff syndrome
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Spinal osteoarthritis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Spinal pain
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
6 / 307 (1.95%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
12 |
0 |
0 |
0 |
Trigger finger
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Bursitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Coccydynia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Gouty arthritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Joint range of motion decreased
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Limb discomfort
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Muscle fatigue
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Muscle twitching
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
0 |
0 |
Musculoskeletal stiffness
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Rhabdomyolysis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Synovial cyst
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Tendon pain
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Tendonitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Infections and infestations
|
|
|
|
|
|
Urinary tract infection
|
|
|
|
|
|
subjects affected / exposed
|
17 / 262 (6.49%) |
22 / 307 (7.17%) |
11 / 130 (8.46%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
24 |
27 |
14 |
1 |
0 |
Pneumonia
|
|
|
|
|
|
subjects affected / exposed
|
12 / 262 (4.58%) |
10 / 307 (3.26%) |
5 / 130 (3.85%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
19 |
11 |
5 |
0 |
0 |
Upper respiratory tract infection
|
|
|
|
|
|
subjects affected / exposed
|
12 / 262 (4.58%) |
42 / 307 (13.68%) |
7 / 130 (5.38%) |
4 / 24 (16.67%) |
1 / 12 (8.33%) |
occurrences all number
|
15 |
49 |
10 |
4 |
1 |
COVID-19
|
|
|
|
|
|
subjects affected / exposed
|
8 / 262 (3.05%) |
9 / 307 (2.93%) |
1 / 130 (0.77%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
8 |
11 |
1 |
1 |
0 |
Sinusitis
|
|
|
|
|
|
subjects affected / exposed
|
8 / 262 (3.05%) |
8 / 307 (2.61%) |
4 / 130 (3.08%) |
2 / 24 (8.33%) |
2 / 12 (16.67%) |
occurrences all number
|
8 |
13 |
5 |
2 |
3 |
Oral candidiasis
|
|
|
|
|
|
subjects affected / exposed
|
7 / 262 (2.67%) |
2 / 307 (0.65%) |
5 / 130 (3.85%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
10 |
2 |
5 |
0 |
0 |
Bronchitis
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
5 / 307 (1.63%) |
5 / 130 (3.85%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
6 |
7 |
10 |
1 |
0 |
Candida infection
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
4 / 307 (1.30%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
4 |
1 |
0 |
0 |
Nasopharyngitis
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
7 / 307 (2.28%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
11 |
2 |
0 |
0 |
Respiratory tract infection
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
5 / 307 (1.63%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
8 |
5 |
0 |
0 |
0 |
Cytomegalovirus infection reactivation
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
8 |
0 |
2 |
0 |
0 |
Cytomegalovirus infection
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
0 |
1 |
0 |
0 |
Folliculitis
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
0 |
0 |
0 |
0 |
Gastroenteritis
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
3 |
0 |
0 |
0 |
Influenza
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
5 / 307 (1.63%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
7 |
1 |
0 |
0 |
Lower respiratory tract infection
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
8 / 307 (2.61%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
9 |
0 |
0 |
0 |
Rhinitis
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
7 |
3 |
0 |
0 |
0 |
Sepsis
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
0 |
1 |
0 |
0 |
Cellulitis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
4 / 307 (1.30%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
2 |
7 |
3 |
0 |
1 |
Chronic sinusitis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
0 |
0 |
Conjunctivitis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
1 |
0 |
0 |
Cystitis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
1 |
1 |
0 |
0 |
Diverticulitis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
0 |
1 |
1 |
0 |
Escherichia infection
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Herpes zoster
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
2 |
1 |
0 |
0 |
Oral herpes
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
2 |
1 |
0 |
0 |
Oral infection
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Pharyngitis
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
0 |
0 |
Skin infection
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
1 |
0 |
Acute sinusitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
2 |
1 |
0 |
0 |
Asymptomatic bacteriuria
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Bacteraemia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
1 |
0 |
0 |
Bronchiolitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Cellulitis of male external genital organ
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Clostridium difficile colitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
3 |
4 |
0 |
0 |
Clostridium difficile infection
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
1 |
0 |
0 |
Cytomegalovirus viraemia
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Ear infection
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Enterocolitis infectious
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Epididymitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Fungal infection
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Gastric infection
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Hordeolum
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Gastrointestinal infection
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Infection
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
0 |
0 |
Latent tuberculosis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Molluscum contagiosum
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Nail infection
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Nasal herpes
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Oesophageal candidiasis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
1 |
0 |
1 |
0 |
1 |
Post procedural infection
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Proctitis herpes
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Pulpitis dental
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Scrotal infection
|
|
|
|
|
|
subjects affected / exposed [20]
|
1 / 157 (0.64%) |
0 / 168 (0.00%) |
0 / 78 (0.00%) |
0 / 16 (0.00%) |
0 / 8 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Sialoadenitis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
0 |
0 |
Tinea cruris
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Tooth infection
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
4 |
0 |
0 |
0 |
Vaginal infection
|
|
|
|
|
|
subjects affected / exposed [21]
|
1 / 105 (0.95%) |
1 / 139 (0.72%) |
0 / 52 (0.00%) |
1 / 8 (12.50%) |
0 / 4 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
1 |
0 |
Viral infection
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
0 |
0 |
Alpha haemolytic streptococcal infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
COVID-19 pneumonia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
0 |
0 |
Campylobacter infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Enterocolitis viral
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Erysipelas
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Eye infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Fungal skin infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
2 |
0 |
0 |
Gastroenteritis norovirus
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Gastroenteritis viral
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
1 |
0 |
0 |
Gastrointestinal viral infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Gingivitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Helicobacter gastritis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Helicobacter infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Herpes simplex
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Herpes virus infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Infected cyst
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Kidney infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Localised infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Measles
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Moraxella infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Neutropenic sepsis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Onychomycosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Ophthalmic herpes simplex
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Oral fungal infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Periorbital cellulitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Pneumonia haemophilus
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Pulmonary mycosis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Septic shock
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Skin bacterial infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Splenic infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Staphylococcal sepsis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Streptococcal bacteraemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Tinea pedis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Tinea versicolour
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Urinary tract infection enterococcal
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Viral pharyngitis
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Viral upper respiratory tract infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
4 / 307 (1.30%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
4 |
1 |
0 |
0 |
Vulvovaginal mycotic infection
|
|
|
|
|
|
subjects affected / exposed [22]
|
0 / 105 (0.00%) |
0 / 139 (0.00%) |
1 / 52 (1.92%) |
0 / 8 (0.00%) |
0 / 4 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Wound infection
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Contusion
|
|
|
|
|
|
subjects affected / exposed
|
10 / 262 (3.82%) |
10 / 307 (3.26%) |
5 / 130 (3.85%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
15 |
11 |
6 |
0 |
0 |
Ligament sprain
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
4 |
2 |
0 |
0 |
0 |
Humerus fracture
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
2 |
0 |
0 |
0 |
1 |
Metabolism and nutrition disorders
|
|
|
|
|
|
Hypokalaemia
|
|
|
|
|
|
subjects affected / exposed
|
38 / 262 (14.50%) |
37 / 307 (12.05%) |
25 / 130 (19.23%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
57 |
62 |
38 |
0 |
0 |
Decreased appetite
|
|
|
|
|
|
subjects affected / exposed
|
37 / 262 (14.12%) |
59 / 307 (19.22%) |
32 / 130 (24.62%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
45 |
83 |
35 |
1 |
0 |
Hypomagnesaemia
|
|
|
|
|
|
subjects affected / exposed
|
22 / 262 (8.40%) |
20 / 307 (6.51%) |
15 / 130 (11.54%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
31 |
26 |
22 |
1 |
0 |
Dehydration
|
|
|
|
|
|
subjects affected / exposed
|
11 / 262 (4.20%) |
18 / 307 (5.86%) |
16 / 130 (12.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
13 |
20 |
20 |
0 |
0 |
Hypophosphataemia
|
|
|
|
|
|
subjects affected / exposed
|
11 / 262 (4.20%) |
12 / 307 (3.91%) |
6 / 130 (4.62%) |
0 / 24 (0.00%) |
1 / 12 (8.33%) |
occurrences all number
|
13 |
22 |
15 |
0 |
2 |
Hyponatraemia
|
|
|
|
|
|
subjects affected / exposed
|
8 / 262 (3.05%) |
6 / 307 (1.95%) |
7 / 130 (5.38%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
10 |
10 |
11 |
0 |
0 |
Hypercalcaemia
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
7 / 307 (2.28%) |
3 / 130 (2.31%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
10 |
3 |
0 |
0 |
Hyperglycaemia
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
8 / 307 (2.61%) |
4 / 130 (3.08%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
5 |
10 |
6 |
1 |
0 |
Hyperuricaemia
|
|
|
|
|
|
subjects affected / exposed
|
5 / 262 (1.91%) |
11 / 307 (3.58%) |
7 / 130 (5.38%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
6 |
14 |
7 |
2 |
0 |
Hypocalcaemia
|
|
|
|
|
|
subjects affected / exposed
|
4 / 262 (1.53%) |
11 / 307 (3.58%) |
5 / 130 (3.85%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
6 |
18 |
5 |
0 |
0 |
Hypercholesterolaemia
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
4 / 307 (1.30%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
8 |
2 |
0 |
0 |
Hyperkalaemia
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
9 / 307 (2.93%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
10 |
0 |
0 |
0 |
Tumour lysis syndrome
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
0 |
0 |
Vitamin D deficiency
|
|
|
|
|
|
subjects affected / exposed
|
3 / 262 (1.15%) |
5 / 307 (1.63%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
3 |
5 |
0 |
0 |
0 |
Gout
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
5 / 307 (1.63%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
5 |
1 |
0 |
0 |
Hyperlipidaemia
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
1 |
0 |
Hypertriglyceridaemia
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
0 |
0 |
Hypoalbuminaemia
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
5 / 307 (1.63%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
5 |
4 |
0 |
0 |
Hypoglycaemia
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
5 / 307 (1.63%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
5 |
0 |
0 |
0 |
Increased appetite
|
|
|
|
|
|
subjects affected / exposed
|
2 / 262 (0.76%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
0 |
0 |
Acidosis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
1 |
0 |
0 |
Diabetes mellitus
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
1 |
0 |
0 |
Fluid overload
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Fluid retention
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
1 |
0 |
0 |
Iron deficiency
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
1 |
0 |
0 |
Magnesium deficiency
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Malnutrition
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
2 / 130 (1.54%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
2 |
0 |
0 |
Metabolic acidosis
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
0 |
0 |
Type 2 diabetes mellitus
|
|
|
|
|
|
subjects affected / exposed
|
1 / 262 (0.38%) |
0 / 307 (0.00%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
0 |
0 |
Abnormal loss of weight
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Cachexia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Failure to thrive
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Hypermagnesaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
2 / 307 (0.65%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
0 |
0 |
Hypernatraemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Hyperphosphataemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
1 |
0 |
0 |
Hypochloraemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Hypoproteinaemia
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Obesity
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
0 / 307 (0.00%) |
1 / 130 (0.77%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
0 |
1 |
0 |
0 |
Vitamin B12 deficiency
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
3 / 307 (0.98%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
0 |
0 |
Zinc deficiency
|
|
|
|
|
|
subjects affected / exposed
|
0 / 262 (0.00%) |
1 / 307 (0.33%) |
0 / 130 (0.00%) |
0 / 24 (0.00%) |
0 / 12 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
0 |
0 |
Myalgia
|
|
|
|
|
|
subjects affected / exposed
|
14 / 262 (5.34%) |
24 / 307 (7.82%) |
4 / 130 (3.08%) |
2 / 24 (8.33%) |
1 / 12 (8.33%) |
occurrences all number
|
15 |
29 |
6 |
3 |
1 |
Neck pain
|
|
|
|
|
|
subjects affected / exposed
|
12 / 262 (4.58%) |
5 / 307 (1.63%) |
5 / 130 (3.85%) |
1 / 24 (4.17%) |
0 / 12 (0.00%) |
occurrences all number
|
13 |
5 |
5 |
1 |
0 |