Kredex (carvedilol) - Product Information (PI) - Roche Australia
Kredex (carvedilol) - Product Information (PI) - Roche Australia
Kredex (carvedilol) - Product Information (PI) - Roche Australia
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Table 3- Adverse events in the COPERNICUS trial occurring with a frequency ≥2%<br />
Body as a Whole<br />
Asthenia<br />
Sudden death<br />
Abdominal pain<br />
Infection<br />
Pain in extremity<br />
Back pain<br />
Accidental injury<br />
Cardiovascular System<br />
Heart failure<br />
Hypotension<br />
Chest Pain<br />
Bradycardia<br />
Syncope (including presyncope)<br />
Angina pectoris<br />
Atrial fibrillation<br />
Ventricular tachycardia<br />
Hypertension<br />
Unstable angina pectoris<br />
AV block first degree<br />
Peripheral vascular disorder<br />
Myocardial infarct<br />
Ventricular fibrillation<br />
Nervous System<br />
Dizziness<br />
Headache<br />
Gastrointestinal<br />
Diarrhoea<br />
Nausea<br />
Adverse Events<br />
KREDEX (n=1156)<br />
% occurrence<br />
10.9<br />
3.9<br />
2.2<br />
2.5<br />
2.1<br />
2.9<br />
1.7<br />
26.0<br />
13.9<br />
6.8<br />
10.3<br />
7.6<br />
5.5<br />
2.2<br />
1.6<br />
2.6<br />
2.0<br />
2.3<br />
1.6<br />
1.6<br />
1.0<br />
24.1<br />
4.8<br />
4.8<br />
3.8<br />
Placebo<br />
(n= 1133)<br />
% occurrence<br />
9.4<br />
6.1<br />
3.0<br />
2.4<br />
2.5<br />
1.4<br />
2.0<br />
31.5<br />
8.2<br />
7.6<br />
2.7<br />
5.0<br />
4.1<br />
4.3<br />
3.9<br />
2.2<br />
2.7<br />
1.6<br />
2.4<br />
2.2<br />
2.1<br />
16.8<br />
3.0<br />
3.1<br />
3.3<br />
Haematology<br />
Anaemia 2.4 2.0<br />
Metabolic<br />
Weight gain<br />
Peripheral oedema<br />
Generalised oedema<br />
Hyperglycaemia<br />
Gout<br />
Hypokalaemia<br />
Hyperkalaemia<br />
Creatinine increased<br />
Diabetes mellitus<br />
11.7<br />
7.0<br />
6.0<br />
4.5<br />
3.5<br />
2.5<br />
3.3<br />
2.9<br />
2.0<br />
10.7<br />
6.4<br />
4.9<br />
3.3<br />
2.7<br />
3.4<br />
1.9<br />
1.4<br />
1.7<br />
Musculoskeletal System<br />
Muscle cramps 2.0 1.2<br />
Respiratory System<br />
Upper respiratory infection<br />
Dyspnea<br />
Bronchitis<br />
Cough increased<br />
Lung oedema<br />
Lung disorder<br />
Pneumonia<br />
Urinogenital System<br />
Kidney function abnormal<br />
Urinary tract infection<br />
13.6<br />
11.2<br />
5.2<br />
4.5<br />
3.5<br />
4.0<br />
3.2<br />
2.1<br />
1.6<br />
12.6<br />
11.0<br />
4.5<br />
4.2<br />
4.1<br />
3.2<br />
3.9<br />
2.3<br />
2.4<br />
Vision<br />
Blurred vision 2.8 2.2<br />
Skin and appendages 7.1 6.9<br />
<strong>Kredex</strong> ® <strong>PI</strong> 110720<br />
CDS 5.0 20 of 24