Patients on MED
|
339
|
398
|
86
|
271
|
92
|
29
|
115
|
75
|
1405
|
Patients on MED with ADR
|
151
|
252
|
18
|
30
|
31
|
5
|
17
|
34
|
538
|
Patients on MED with ADR(%)
|
(44.5)
|
(63.3)
|
(20.9)
|
(11.1)
|
(33.7)
|
(17.2)
|
(14.8)
|
(45.3)
|
(38,3)
|
Infections
|
9
|
20
|
–
|
2
|
3
|
2
|
5
|
2
|
43
|
Blood and lymphatic system disorders:
|
- Persistent anemia
|
–
|
1
|
–
|
–
|
–
|
–
|
–
|
–
|
1
|
- Leukopenia/Lymphopenia
|
–
|
–
|
–
|
–
|
–
|
–
|
6
|
4
|
10
|
- Pancytopenia/Neutropenia
|
–
|
–
|
–
|
–
|
–
|
–
|
1
|
–
|
1
|
Immune system disorders:
|
- MAS
|
–
|
–
|
1
|
–
|
–
|
–
|
–
|
–
|
1
|
Endocrine disorders:
|
- Cushing syndrome
|
122
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
122
|
- Obesity
|
3
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
3
|
Metabolism and nutrition disorders:
|
-Osteoporosis*/ Low bone mineral density
|
51
|
9
|
–
|
–
|
–
|
–
|
–
|
–
|
60
|
Nervous system disorders:
|
- Chronic headache/dizziness/discomfort
|
8
|
32
|
0
|
1
|
–
|
2
|
–
|
4
|
47
|
- Pseudotumor cerebri
|
2
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
2
|
-↓ convulsive threshold
|
–
|
–
|
1
|
–
|
–
|
–
|
–
|
–
|
1
|
Eye disorders:
|
- Glaucoma
|
2
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
2
|
- Cataract
|
19
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
19
|
- Maculopathy
|
–
|
–
|
–
|
16
|
–
|
–
|
–
|
–
|
16
|
- Blurred vision
|
–
|
1
|
–
|
–
|
–
| |
–
|
–
|
1
|
Cardiovascular disorders:
|
- Arterial hypertension
|
42
|
–
|
–
|
–
|
3
|
–
|
–
|
–
|
45
|
- Arrhythmia
|
–
|
–
|
–
|
1
|
–
|
–
|
1
|
–
|
2
|
- Edema
|
4
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
4
|
Gastrointestinal disorders:
|
- Nausea/vomiting
|
10
|
199
|
4
|
6
|
17
|
–
|
2
|
28
|
266
|
- Epigastric/abdominal pain
|
7
|
73
|
2
|
2
|
6
|
–
|
2
|
1
|
93
|
- Diarrhea
|
–
|
8
|
–
|
1
|
–
|
2
|
–
|
–
|
11
|
- Hyporexia
|
–
|
7
|
–
|
–
|
1
|
–
|
–
|
–
|
8
|
- Constipation
|
–
|
1
|
–
|
–
|
–
|
–
|
–
|
1
|
2
|
Hepatobiliary disorders:
|
- ↑ liver enzymes
|
2
|
68
|
7
|
1
|
1
|
–
|
5
|
1
|
85
|
- Hepatic steatosis
|
1
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
1
|
- Jaundice
|
–
|
–
|
1
|
1
|
–
|
–
|
–
|
–
|
2
|
Oral disorders:
| | | | | | | | | |
- Mouth ulcers
|
–
|
3
|
1
|
–
|
–
|
–
|
–
|
–
|
4
|
- Mucositis
|
–
|
3
|
–
|
–
|
–
|
–
|
–
|
–
|
3
|
- Gingival hyperplasia
|
–
|
–
|
–
|
–
|
2
|
–
|
–
|
–
|
2
|
Skin and subcutaneous tissue disorders:
|
- Striae
|
3
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
3
|
- Atopic dermatitis
|
–
|
–
|
–
|
1
|
–
|
–
|
–
|
–
|
1
|
- Alopecia
|
–
|
5
|
4
|
–
|
–
|
–
|
1
|
10
|
20
|
- Hypertrichosis
|
–
|
–
|
–
|
–
|
7
|
–
|
–
|
–
|
7
|
- Urticaria
|
4
|
5
|
1
|
2
|
2
|
–
|
–
|
–
|
14
|
Musculoskeletal and connective tissue disorders:
|
-↑ muscle enzymes
|
–
|
–
|
–
|
1
|
–
|
–
|
–
|
–
|
1
|
- Myositis
|
–
|
–
|
–
|
1
|
–
|
–
|
–
|
–
|
1
|
- Myalgia
|
3
|
–
|
–
|
–
|
–
|
–
|
–
|
–
|
3
|
Renal and urinary disorders:
|
-↑ urea
|
–
|
–
|
–
|
–
|
1
|
–
|
–
|
–
|
1
|
General disorders and administration site conditions:
|
- Infusion reactions and pain
|
3
|
4
|
–
|
–
|
–
|
–
|
–
|
–
|
7
|
Total number of ADRs
|
295
|
439
|
22
|
36
|
43
|
6
|
23
|
51
|
915
|