|
TOTAL
|
1687
|
264
|
67.9%
|
136
|
882
|
297
|
70.5%
|
131
|
|
Eye disorders
|
65
|
40
|
10.3%
|
5.24
|
28
|
22
|
5.2%
|
4.15
|
|
Uveitis
|
15
|
9
|
2.3%
|
1.21
|
13
|
9
|
2.1%
|
1.93
|
|
Gastrointestinal disorders
|
154
|
72
|
18.5%
|
12.4
|
56
|
39
|
9.3%
|
8.3
|
|
Diarrhea
|
24
|
16
|
4.1%
|
1.93
|
13
|
12
|
2.9%
|
1.93
|
|
Dyspepsia
|
10
|
9
|
2.3%
|
0.81
|
3
|
3
|
0.7%
|
0.44
|
|
Nausea
|
27
|
19
|
4.9%
|
2.18
|
10
|
7
|
1.7%
|
1.48
|
|
Vomiting
|
13
|
12
|
3.1%
|
1.05
|
4
|
4
|
1.0%
|
0.59
|
|
General disorders and administration site conditions
|
154
|
86
|
22.1%
|
12.4
|
176
|
156
|
37.1%
|
26.1
|
|
Chest pain
|
18
|
13
|
3.3%
|
1.45
|
2
|
2
|
0.5%
|
0.3
|
|
Chills
|
17
|
8
|
2.1%
|
1.37
|
1
|
1
|
0.2%
|
0.15
|
|
Drug effect decreased
|
8
|
7
|
1.8%
|
0.64
|
27
|
26
|
6.2%
|
4.0
|
|
Drug ineffective
|
12
|
12
|
3.1%
|
0.97
|
90
|
88
|
20.9%
|
13.3
|
|
Fatigue
|
26
|
16
|
4.1%
|
2.10
|
10
|
9
|
2.1%
|
1.48
|
|
Pain
|
21
|
16
|
4.1%
|
1.69
|
0
|
0
|
0
|
0
|
|
Pyrexia
|
12
|
10
|
2.6%
|
0.97
|
6
|
5
|
1.2%
|
0.89
|
|
Therapeutic response decreased
|
8
|
8
|
2.1%
|
0.64
|
25
|
25
|
5.9%
|
3.7
|
|
Infections and infestations
|
408
|
149
|
38.3%
|
32.9
|
309
|
129
|
30.6%
|
45.8
|
|
Bronchitis
|
17
|
11
|
2.8%
|
1.37
|
16
|
16
|
3.8%
|
2.37
|
|
Ear infection
|
11
|
11
|
2.8%
|
0.89
|
13
|
13
|
3.1%
|
1.93
|
|
Gastroenteritis
|
17
|
15
|
3.9%
|
1.37
|
5
|
3
|
0.7%
|
0.74
|
|
Influenza
|
15
|
15
|
3.9%
|
1.21
|
10
|
8
|
1.9%
|
1.48
|
|
Nasopharyngitis
|
70
|
44
|
11.3%
|
5.64
|
59
|
31
|
7.4%
|
8.74
|
|
Pneumonia
|
22
|
18
|
4.6%
|
1.77
|
8
|
8
|
1.9%
|
1.19
|
|
Sinusitis
|
37
|
26
|
6.7%
|
2.98
|
27
|
18
|
4.3%
|
4.00
|
|
Tooth abscess
|
8
|
8
|
2.1%
|
0.64
|
3
|
3
|
0.7
|
0.44
|
|
Upper respiratory tract infection
|
36
|
28
|
7.2%
|
2.90
|
47
|
30
|
7.1%
|
1.33
|
|
Urinary tract infection
|
34
|
19
|
4.9%
|
2.74
|
9
|
9
|
2.1%
|
1.33
|
|
Injury, poisoning and procedural complications
|
89
|
52
|
13.4%
|
7.17
|
29
|
25
|
5.9%
|
4.3
|
|
Fall
|
12
|
10
|
2.6%
|
0.97
|
5
|
4
|
1.0%
|
0.74
|
|
Infusion-related reaction
|
30
|
16
|
4.1%
|
2.42
|
0
|
0
|
0
|
0
|
|
Investigations
|
53
|
38
|
9.8%
|
4.27
|
10
|
10
|
2.4%
|
1.48
|
|
Hepatic enzyme increased
|
12
|
11
|
2.8%
|
0.97
|
3
|
3
|
0.7%
|
0.44
|
|
Musculoskeletal and connective tissue disorders
|
263
|
80
|
20.6%
|
21.2
|
65
|
45
|
10.7%
|
9.63
|
|
Ankylosing spondylitis
|
11
|
10
|
2.6%
|
0.89
|
2
|
2
|
0.5%
|
0.30
|
|
Arthralgia
|
62
|
31
|
8.0%
|
5.00
|
9
|
7
|
1.7%
|
1.33
|
|
Back pain
|
53
|
28
|
7.2%
|
4.27
|
9
|
9
|
2.1%
|
1.33
|
|
Musculoskeletal pain
|
10
|
8
|
2.1%
|
0.81
|
2
|
2
|
0.5%
|
0.3
|
|
Neck pain
|
18
|
14
|
3.6%
|
1.45
|
3
|
3
|
0.7%
|
0.44
|
|
Pain in extremity
|
38
|
20
|
5.1%
|
3.06
|
8
|
8
|
1.9%
|
1.19
|
|
Nervous system disorders
|
80
|
46
|
11.8%
|
6.45
|
34
|
29
|
6.9%
|
5.04
|
|
Headache
|
27
|
21
|
5.4%
|
2.18
|
8
|
7
|
1.7%
|
1.19
|
|
Hypoaesthesia
|
22
|
12
|
3.1%
|
1.77
|
2
|
2
|
0.5%
|
0.3
|
|
Respiratory, thoracic and mediastinal disorders
|
99
|
56
|
14.4%
|
7.98
|
27
|
19
|
4.5%
|
4.00
|
|
Cough
|
20
|
17
|
4.4%
|
1.61
|
7
|
7
|
1.7%
|
1.04
|
|
Dyspnoea
|
12
|
11
|
2.8%
|
0.97
|
0
|
0
|
0
|
0
|
|
Oropharyngeal pain
|
22
|
12
|
3.1%
|
1.77
|
6
|
5
|
1.2%
|
0.89
|
|
Skin and subcutaneous tissue disorders
|
119
|
63
|
16.2%
|
9.59
|
59
|
39
|
9.3%
|
8.74
|
|
Pruritus
|
24
|
19
|
4.9%
|
1.93
|
0
|
0
|
0
|
0
|
|
Psoriasis
|
15
|
8
|
2.1%
|
1.21
|
12
|
9
|
2.1%
|
1.33
|
|
Rash
|
16
|
12
|
3.1%
|
1.29
|
9
|
9
|
2.1%
|
1.33
|
|
Vascular disorders
|
50
|
30
|
7.7%
|
4.03
|
9
|
8
|
1.9%
|
1.33
|
|
Hypertension
|
20
|
15
|
3.9%
|
1.61
|
6
|
6
|
1.4%
|
0.89
|
