Adverse events by system organ class, preferred term and severity
(Safety Set)
System Organ Class/ Preferred
Terms, n (%)
Mild
Moderate
Severe
Total
Safety Set
125 (100%)
47 (100%)
6 (100%)
178 (100%)
Results in Deaths
NA
NA
1 (16.667%)
1 (0.562%)
CARDIAC DISORDERS
31 (46.97%)
15 (55.556%)
4 (66.667%)
44 (51.765%)
Atrial Fibrillation
2 (3.03%)
2 (7.407%)
1 (16.667%)
5 (5.882%)
Atrial Flutter
1 (1.515%)
1 (3.704%)
0
2 (2.353%)
Atrial Hypertrophy
1 (1.515%)
0
0
1 (1.176%)
Atrioventricular Block First
Degree
2 (3.03%)
0
0
2 (2.353%)
Atrioventricular Block Second
Degree
2 (3.03%)
2 (7.407%)
1 (16.667%)
5 (5.882%)
Bradycardia
1 (1.515%)
0
0
1 (1.176%)
Bundle Branch Block Left
1 (1.515%)
0
0
1 (1.176%)
Bundle Branch Block Right
1 (1.515%)
1 (3.704%)
0
2 (2.353%)
Cardiac Disorder
1 (1.515%)
0
0
1 (1.176%)
Cardiac Failure Congestive
0
1 (3.704%)
0
1 (1.176%)
Myocardial Infarction
6 (9.091%)
2 (7.407%)
2 (33.333%)
10 (11.765%)
Palpitations
0
2 (7.407%)
0
2 (2.353%)
Sinus Arrhythmia
1 (1.515%)
0
0
1 (1.176%)
Sinus Bradycardia
11 (16.667%)
6 (22.222%)
0
17 (20%)
Supraventricular Extrasystoles
3 (4.545%)
0
0
3 (3.529%)
Supraventricular Tachycardia
0
1 (3.704%)
0
1 (1.176%)
Tachycardia
1 (1.515%)
1 (3.704%)
0
1 (1.176%)
Ventricular Extrasystoles
2 (3.03%)
1 (3.704%)
0
3 (3.529%)
Ventricular Hypertrophy
1 (1.515%)
0
0
1 (1.176%)
Wolff-Parkinson-White
Syndrome
1 (1.515%)
0
0
1 (1.176%)
GASTROINTESTINAL
DISORDERS
42 (63.636%)
12 (44.444%)
2 (33.333%)
53 (62.353%)
Abdominal Discomfort
1 (1.515%)
0
0
1 (1.176%)
Abdominal Pain
4 (6.061%)
2 (7.407%)
0
5 (5.882%)
Only 'CARDIAC DISORDERS' and 'GASTROINTESTINAL DISORDERS' System Organ Class have been displayed.
Adverse events by system organ class, preferred term and severity
(Safety Set)
System Organ Class/ Preferred
Terms, n (%)
Mild
Moderate
Severe
Total
Constipation
1 (1.515%)
0
0
1 (1.176%)
Diarrhoea
16 (24.242%)
2 (7.407%)
0
18 (21.176%)
Dyspepsia
1 (1.515%)
2 (7.407%)
0
3 (3.529%)
Dysphagia
0
1 (3.704%)
0
1 (1.176%)
Flatulence
1 (1.515%)
0
0
1 (1.176%)
Gastrointestinal Haemorrhage
0
0
1 (16.667%)
1 (1.176%)
Gastrooesophageal Reflux
Disease
1 (1.515%)
0
0
1 (1.176%)
Glossitis
1 (1.515%)
0
0
1 (1.176%)
Hiatus Hernia
0
1 (3.704%)
0
1 (1.176%)
Nausea
9 (13.636%)
3 (11.111%)
1 (16.667%)
12 (14.118%)
Rectal Haemorrhage
1 (1.515%)
0
0
1 (1.176%)
Salivary Hypersecretion
4 (6.061%)
0
0
4 (4.706%)
Stomach Discomfort
1 (1.515%)
0
0
1 (1.176%)
Vomiting
9 (13.636%)
4 (14.815%)
0
13 (15.294%)
Only 'CARDIAC DISORDERS' and 'GASTROINTESTINAL DISORDERS' System Organ Class have been displayed.
