Kredex (carvedilol) - Product Information (PI) - Roche Australia

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