No AE
|
962
|
71.3
|
463
|
70.0
|
Any AE
|
388
|
28.7
|
198
|
30.0
|
Serious AE
|
168
|
12.4
|
101
|
15.3
|
Not serious
|
345
|
25.6
|
176
|
26.6
|
MedDRA
®
primary System Organ Classes (SOC) V. 11.1 - (Serious) Adverse Events, n = 2011 (%)
|
Ramipril
|
Diuretic
|
|
AE
|
SAE
|
AE
|
SAE
|
Musculosceletal and connective tissue disorders
|
6.52
|
0.74
|
11.95
|
0.61
|
Infections and infestations
|
6.22
|
0.37
|
9.98
|
0.45
|
Metabolism and nutrition disorders
|
5.78
|
0.22
|
8.02
|
1.06
|
Respiratory, thoracic and mediastinal disorders
|
5.93
|
0.22
|
3.03
|
0.45
|
Nervous system disorders
|
3.41
|
1.70
|
6.66
|
3.78
|
Gastrointestinal disorders
|
3.48
|
1.04
|
4.24
|
1.36
|
Cardiac disorders
|
3.04
|
2.74
|
4.54
|
3.18
|
Vascular disorders
|
3.26
|
1.48
|
2.57
|
1.36
|
General disorders and administration site conditions
|
2.07
|
1.93
|
3.48
|
3.03
|
Injury, poisoning and procedural complications
|
2.22
|
1.04
|
3.18
|
1.36
|
Surgical and medical procedures
|
2.00
|
0.89
|
2.87
|
1.51
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
1.93
|
2.22
|
2.12
|
2.12
|