Time Frame |
On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
|
Adverse Event Reporting Description |
ITT Population comprised of all randomized participants who received at least one prescription of study medication
|
|
Arm/Group Title
|
Usual Care
|
FF/VI
|
Arm/Group Description |
Participants continued their usual ...
|
Participants initiated with an appr...
|
Arm/Group Description |
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
|
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
|
|
|
Usual Care
|
FF/VI
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
27/2119 (1.27%)
|
|
15/2114 (0.71%)
|
|
|
|
Usual Care
|
FF/VI
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
284/2119 (13.40%)
|
|
284/2114 (13.43%)
|
|
Blood and lymphatic system disorders |
|
|
Anaemia |
3/2119 (0.14%)
|
3 |
3/2114 (0.14%)
|
3 |
Anaemia of chronic disease |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Lymphadenopathy mediastinal |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Microcytic anaemia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Pancytopenia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Thrombocytopenia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Cardiac disorders |
|
|
Acute coronary syndrome |
1/2119 (0.05%)
|
2 |
1/2114 (0.05%)
|
1 |
Acute myocardial infarction |
2/2119 (0.09%)
|
2 |
4/2114 (0.19%)
|
4 |
Angina pectoris |
1/2119 (0.05%)
|
1 |
5/2114 (0.24%)
|
5 |
Angina unstable |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Arrhythmia |
3/2119 (0.14%)
|
3 |
2/2114 (0.09%)
|
2 |
Arteriosclerosis coronary artery |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Atrial fibrillation |
14/2119 (0.66%)
|
16 |
7/2114 (0.33%)
|
7 |
Atrioventricular block first degree |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Cardiac arrest |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Cardiac failure |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Cardiac failure congestive |
2/2119 (0.09%)
|
2 |
1/2114 (0.05%)
|
1 |
Cardiac ventricular thrombosis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Coronary artery disease |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Coronary artery thrombosis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Diastolic dysfunction |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Hypertensive heart disease |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Left ventricular dysfunction |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Left ventricular failure |
0/2119 (0.00%)
|
0 |
3/2114 (0.14%)
|
3 |
Left ventricular hypertrophy |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Myocardial infarction |
2/2119 (0.09%)
|
2 |
2/2114 (0.09%)
|
2 |
Myocardial ischaemia |
2/2119 (0.09%)
|
2 |
5/2114 (0.24%)
|
5 |
Myocarditis |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Palpitations |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Sinus bradycardia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Sinus node dysfunction |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Tricuspid valve incompetence |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Ventricular extrasystoles |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Ventricular tachycardia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Congenital, familial and genetic disorders |
|
|
Branchial cyst |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Endocardial fibroelastosis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Ear and labyrinth disorders |
|
|
Deafness |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Tinnitus |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Vertigo |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Vertigo positional |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Endocrine disorders |
|
|
Adrenal insufficiency |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Hyperparathyroidism |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Hyperthyroidism |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Hypothyroidism |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Inappropriate antidiuretic hormone secretion |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Secondary hypogonadism |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Eye disorders |
|
|
Angle closure glaucoma |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Cataract |
4/2119 (0.19%)
|
4 |
6/2114 (0.28%)
|
6 |
Conjunctivitis allergic |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Diabetic retinopathy |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Glaucoma |
0/2119 (0.00%)
|
0 |
4/2114 (0.19%)
|
4 |
Ocular hyperaemia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Retinal detachment |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Gastrointestinal disorders |
|
|
Abdominal hernia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Abdominal pain |
4/2119 (0.19%)
|
4 |
5/2114 (0.24%)
|
5 |
Abdominal wall haematoma |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Colitis ischaemic |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Colitis ulcerative |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
2 |
Constipation |
5/2119 (0.24%)
|
5 |
1/2114 (0.05%)
|
1 |
Diarrhoea |
0/2119 (0.00%)
|
0 |
4/2114 (0.19%)
|
4 |
Diverticulum |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Duodenal ulcer |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Dysphagia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Gastritis |
5/2119 (0.24%)
|
5 |
1/2114 (0.05%)
|
1 |
Gastrointestinal disorder |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Gastrointestinal haemorrhage |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Gastrooesophageal reflux disease |
2/2119 (0.09%)
|
2 |
3/2114 (0.14%)
|
3 |
Haematemesis |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Incarcerated umbilical hernia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Intestinal ischaemia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Intestinal obstruction |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Large intestinal obstruction |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Melaena |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Oesophagitis |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Pancreatitis |
1/2119 (0.05%)
|
1 |
3/2114 (0.14%)
|
3 |
Pancreatitis acute |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Proctalgia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Rectal haemorrhage |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Umbilical hernia, obstructive |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Upper gastrointestinal haemorrhage |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Vomiting |
1/2119 (0.05%)
|
1 |
2/2114 (0.09%)
|
2 |
General disorders |
|
|
Chest pain |
4/2119 (0.19%)
|
4 |
1/2114 (0.05%)
|
1 |
Generalised oedema |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Multiple organ dysfunction syndrome |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Non-cardiac chest pain |
3/2119 (0.14%)
|
3 |
1/2114 (0.05%)
|
1 |
Peripheral swelling |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Surgical failure |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Hepatobiliary disorders |
|
|
Bile duct stone |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Cholecystitis |
3/2119 (0.14%)
|
3 |
1/2114 (0.05%)
|
2 |
Cholelithiasis |
1/2119 (0.05%)
|
1 |
3/2114 (0.14%)
|
3 |
Hepatic cirrhosis |
2/2119 (0.09%)
|
2 |
1/2114 (0.05%)
|
1 |
Hepatic failure |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Hepatic function abnormal |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Jaundice cholestatic |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Immune system disorders |
|
|
Anaphylactic reaction |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Hypersensitivity |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Mycotic allergy |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Infections and infestations |
|
|
Abdominal abscess |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Abdominal wall abscess |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Abscess |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Anal abscess |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Appendicitis |
2/2119 (0.09%)
|
2 |
1/2114 (0.05%)
|
1 |
Atypical pneumonia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Bacteraemia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Biliary sepsis |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Bronchiolitis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Candida infection |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Catheter site infection |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Cellulitis |
11/2119 (0.52%)
|
13 |
7/2114 (0.33%)
|
8 |
Chronic hepatitis C |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Diverticulitis |
1/2119 (0.05%)
|
1 |
3/2114 (0.14%)
|
3 |
Empyema |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Encephalitis |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Gastroenteritis |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Genital herpes |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Genital infection |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Infected dermal cyst |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Infected skin ulcer |
3/2119 (0.14%)
|
3 |
0/2114 (0.00%)
|
0 |
Infective exacerbation of chronic obstructive airways disease |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Kidney infection |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Liver abscess |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Localised infection |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Lower respiratory tract infection |
7/2119 (0.33%)
|
7 |
5/2114 (0.24%)
|
5 |
Necrotising fasciitis |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Neutropenic sepsis |
1/2119 (0.05%)
|
1 |
2/2114 (0.09%)
|
2 |
Ophthalmic herpes simplex |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Pelvic inflammatory disease |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Periorbital cellulitis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Peritonsillar abscess |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Pilonidal cyst |
2/2119 (0.09%)
|
3 |
1/2114 (0.05%)
|
1 |
Pneumonia |
13/2119 (0.61%)
|
14 |
23/2114 (1.09%)
|
24 |
Pneumonia mycoplasmal |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Post procedural infection |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Post procedural sepsis |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Postoperative wound infection |
1/2119 (0.05%)
|
1 |
2/2114 (0.09%)
|
2 |
Pseudomonas infection |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Pyelonephritis |
3/2119 (0.14%)
|
3 |
1/2114 (0.05%)
|
1 |
Respiratory tract infection |
0/2119 (0.00%)
|
0 |
3/2114 (0.14%)
|
3 |
Sepsis |
7/2119 (0.33%)
|
7 |
3/2114 (0.14%)
|
3 |
Sialoadenitis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Staphylococcal infection |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Subcutaneous abscess |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Tonsillitis |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Upper respiratory tract infection |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Urinary tract infection |
4/2119 (0.19%)
|
4 |
12/2114 (0.57%)
|
13 |
Urosepsis |
2/2119 (0.09%)
|
2 |
1/2114 (0.05%)
|
1 |
Viral infection |
2/2119 (0.09%)
|
2 |
1/2114 (0.05%)
|
1 |
Viral labyrinthitis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Vulval abscess |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Wound infection |
2/2119 (0.09%)
|
2 |
1/2114 (0.05%)
|
1 |
Injury, poisoning and procedural complications |
|
|
Accidental overdose |
3/2119 (0.14%)
|
3 |
2/2114 (0.09%)
|
2 |
Ankle fracture |
2/2119 (0.09%)
|
2 |
8/2114 (0.38%)
|
8 |
Brain contusion |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Burns third degree |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Cervical vertebral fracture |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Comminuted fracture |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Corneal abrasion |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Craniocerebral injury |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Facial bones fracture |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Fall |
5/2119 (0.24%)
|
5 |
6/2114 (0.28%)
|
6 |
Femoral neck fracture |
2/2119 (0.09%)
|
2 |
2/2114 (0.09%)
|
2 |
Femur fracture |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Fibula fracture |
2/2119 (0.09%)
|
2 |
1/2114 (0.05%)
|
1 |
Foot fracture |
3/2119 (0.14%)
|
3 |
3/2114 (0.14%)
|
3 |
Foreign body |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Fracture |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Hand fracture |
4/2119 (0.19%)
|
5 |
1/2114 (0.05%)
|
1 |
Head injury |
3/2119 (0.14%)
|
3 |
1/2114 (0.05%)
|
1 |
Humerus fracture |
5/2119 (0.24%)
|
5 |
2/2114 (0.09%)
|
2 |
Intentional overdose |
5/2119 (0.24%)
|
5 |
5/2114 (0.24%)
|
5 |
Intentional product misuse |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Joint dislocation |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Ligament rupture |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
2 |
Limb crushing injury |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Limb injury |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Meniscus injury |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Overdose |
1/2119 (0.05%)
|
1 |
2/2114 (0.09%)
|
2 |
Pelvic fracture |
2/2119 (0.09%)
|
2 |
1/2114 (0.05%)
|
1 |
Post procedural complication |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Post procedural haematoma |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Post procedural haemorrhage |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Pubis fracture |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Radius fracture |
9/2119 (0.42%)
|
10 |
4/2114 (0.19%)
|
4 |
Rib fracture |
1/2119 (0.05%)
|
1 |
2/2114 (0.09%)
|
2 |
Skull fracture |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Skull fractured base |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Soft tissue injury |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Spinal fracture |
1/2119 (0.05%)
|
1 |
2/2114 (0.09%)
|
2 |
Subarachnoid haemorrhage |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Subdural haematoma |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Thermal burn |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Toxicity to various agents |
1/2119 (0.05%)
|
1 |
2/2114 (0.09%)
|
2 |
Ulna fracture |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Upper limb fracture |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Wound secretion |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Wrist fracture |
3/2119 (0.14%)
|
3 |
5/2114 (0.24%)
|
5 |
Investigations |
|
|
Blood potassium decreased |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Electrocardiogram QT prolonged |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
International normalised ratio abnormal |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Liver function test abnormal |
7/2119 (0.33%)
|
7 |
11/2114 (0.52%)
|
11 |
Renal function test abnormal |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Metabolism and nutrition disorders |
|
|
Dehydration |
2/2119 (0.09%)
|
2 |
1/2114 (0.05%)
|
1 |
Diabetes mellitus |
3/2119 (0.14%)
|
3 |
3/2114 (0.14%)
|
3 |
Diabetic ketoacidosis |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Electrolyte imbalance |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Glucose tolerance impaired |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Gout |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Hypercalcaemia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Hyperglycaemia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Hyperkalaemia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Hypokalaemia |
1/2119 (0.05%)
|
1 |
4/2114 (0.19%)
|
4 |
Hyponatraemia |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Malnutrition |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Metabolic acidosis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Type 2 diabetes mellitus |
13/2119 (0.61%)
|
13 |
12/2114 (0.57%)
|
12 |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Arthritis |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Back pain |
8/2119 (0.38%)
|
9 |
3/2114 (0.14%)
|
3 |
Bursitis |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Fibromyalgia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Intervertebral disc protrusion |
3/2119 (0.14%)
|
3 |
0/2114 (0.00%)
|
0 |
Metatarsalgia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Muscular weakness |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Musculoskeletal chest pain |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Musculoskeletal pain |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Osteoarthritis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Osteopenia |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Osteoporosis |
1/2119 (0.05%)
|
1 |
5/2114 (0.24%)
|
5 |
Palindromic rheumatism |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Polymyalgia rheumatica |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Rhabdomyolysis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Rheumatoid arthritis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Acinic cell carcinoma of salivary gland |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Acute myeloid leukaemia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Adenoma benign |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
B-cell lymphoma recurrent |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Basal cell carcinoma |
2/2119 (0.09%)
|
6 |
4/2114 (0.19%)
|
4 |
Bladder cancer |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Bladder transitional cell carcinoma |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Brain cancer metastatic |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Brain neoplasm |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Breast cancer |
2/2119 (0.09%)
|
2 |
2/2114 (0.09%)
|
2 |
Breast cancer metastatic |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Central nervous system lymphoma |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Chondrosarcoma |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Colon cancer |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Colorectal cancer metastatic |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Endometrial adenocarcinoma |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Gastrointestinal carcinoma |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Gastrointestinal stromal tumour |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Hepatocellular carcinoma |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Invasive ductal breast carcinoma |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Lentigo maligna |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Lung cancer metastatic |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Lung neoplasm malignant |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Malignant melanoma |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Malignant melanoma in situ |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Metastases to central nervous system |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Metastases to liver |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Metastases to lung |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Metastatic renal cell carcinoma |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Neoplasm malignant |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Oesophageal carcinoma |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Penile squamous cell carcinoma |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Phyllodes tumour |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Precursor B-lymphoblastic lymphoma |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Prostate cancer |
4/2119 (0.19%)
|
4 |
3/2114 (0.14%)
|
3 |
Renal cancer |
1/2119 (0.05%)
|
1 |
2/2114 (0.09%)
|
2 |
Renal cancer recurrent |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Renal neoplasm |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Squamous cell carcinoma |
1/2119 (0.05%)
|
1 |
2/2114 (0.09%)
|
2 |
Thyroid cancer |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Ureteric cancer |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Nervous system disorders |
|
|
Amnesia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Anosmia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Carpal tunnel syndrome |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Cerebrovascular accident |
0/2119 (0.00%)
|
0 |
5/2114 (0.24%)
|
5 |
Cerebrovascular disorder |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Dementia |
1/2119 (0.05%)
|
1 |
2/2114 (0.09%)
|
2 |
Dizziness |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Drug withdrawal convulsions |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Epilepsy |
2/2119 (0.09%)
|
2 |
1/2114 (0.05%)
|
1 |
Haemorrhage intracranial |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Haemorrhagic stroke |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Headache |
4/2119 (0.19%)
|
4 |
2/2114 (0.09%)
|
2 |
Ischaemic stroke |
1/2119 (0.05%)
|
1 |
3/2114 (0.14%)
|
3 |
Migraine |
2/2119 (0.09%)
|
2 |
5/2114 (0.24%)
|
5 |
Multiple sclerosis |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Multiple sclerosis relapse |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Neuralgia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Neuropathy peripheral |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Paraesthesia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Parkinson's disease |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Radiculopathy |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Sciatica |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Seizure |
0/2119 (0.00%)
|
0 |
5/2114 (0.24%)
|
5 |
Sensory disturbance |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Spinal cord compression |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Status epilepticus |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Subdural hygroma |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Syncope |
2/2119 (0.09%)
|
2 |
3/2114 (0.14%)
|
3 |
Transient ischaemic attack |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Trigeminal neuralgia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
VIth nerve paralysis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Vascular dementia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Vertebral artery dissection |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Vocal cord paralysis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Pregnancy, puerperium and perinatal conditions |
|
|
Abortion missed |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Abortion spontaneous |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Unintended pregnancy |
3/2119 (0.14%)
|
3 |
3/2114 (0.14%)
|
3 |
Unwanted pregnancy |
2/2119 (0.09%)
|
2 |
2/2114 (0.09%)
|
2 |
Product Issues |
|
|
Device dislocation |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Psychiatric disorders |
|
|
Alcohol withdrawal syndrome |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
3 |
Alcoholism |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Antisocial personality disorder |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Bipolar disorder |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Confusional state |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Delusion |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Depressed mood |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Depression |
2/2119 (0.09%)
|
2 |
4/2114 (0.19%)
|
4 |
Depression suicidal |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Eating disorder |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Hypomania |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Persistent depressive disorder |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Post-traumatic stress disorder |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Psychotic disorder |
1/2119 (0.05%)
|
1 |
2/2114 (0.09%)
|
2 |
Schizoaffective disorder |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Suicidal ideation |
2/2119 (0.09%)
|
2 |
3/2114 (0.14%)
|
3 |
Suicide attempt |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Renal and urinary disorders |
|
|
Acute kidney injury |
9/2119 (0.42%)
|
9 |
6/2114 (0.28%)
|
6 |
Chronic kidney disease |
5/2119 (0.24%)
|
5 |
3/2114 (0.14%)
|
3 |
Haematuria |
2/2119 (0.09%)
|
2 |
1/2114 (0.05%)
|
1 |
Hydronephrosis |
0/2119 (0.00%)
|
0 |
2/2114 (0.09%)
|
2 |
Loin pain haematuria syndrome |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Nephrolithiasis |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Renal colic |
1/2119 (0.05%)
|
1 |
2/2114 (0.09%)
|
2 |
Renal impairment |
3/2119 (0.14%)
|
3 |
3/2114 (0.14%)
|
3 |
Ureteric obstruction |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Urinary retention |
4/2119 (0.19%)
|
4 |
2/2114 (0.09%)
|
2 |
Reproductive system and breast disorders |
|
|
Menorrhagia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Oedema genital |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Ovarian cyst |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Ovarian cyst torsion |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Pelvic pain |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Prostatitis |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Uterine haemorrhage |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
Asthma |
30/2119 (1.42%)
|
34 |
24/2114 (1.14%)
|
30 |
Atelectasis |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Bronchiectasis |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Chronic obstructive pulmonary disease |
5/2119 (0.24%)
|
6 |
1/2114 (0.05%)
|
1 |
Emphysema |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Epistaxis |
3/2119 (0.14%)
|
3 |
1/2114 (0.05%)
|
1 |
Interstitial lung disease |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Pharyngeal inflammation |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Pickwickian syndrome |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Pleurisy |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Pneumonia aspiration |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Pulmonary embolism |
2/2119 (0.09%)
|
2 |
2/2114 (0.09%)
|
2 |
Pulmonary eosinophilia |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Pulmonary oedema |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Reflux laryngitis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Respiratory arrest |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Respiratory failure |
2/2119 (0.09%)
|
2 |
2/2114 (0.09%)
|
2 |
Sleep apnoea syndrome |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Skin and subcutaneous tissue disorders |
|
|
Decubitus ulcer |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Dermatitis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Eczema |
2/2119 (0.09%)
|
2 |
1/2114 (0.05%)
|
1 |
Rash |
0/2119 (0.00%)
|
0 |
3/2114 (0.14%)
|
3 |
Skin necrosis |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Skin ulcer |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Surgical and medical procedures |
|
|
Abortion induced |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Vascular disorders |
|
|
Angiodysplasia |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Aortic stenosis |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Circulatory collapse |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Deep vein thrombosis |
2/2119 (0.09%)
|
2 |
5/2114 (0.24%)
|
6 |
Essential hypertension |
1/2119 (0.05%)
|
1 |
1/2114 (0.05%)
|
1 |
Haematoma |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Hypertension |
2/2119 (0.09%)
|
2 |
0/2114 (0.00%)
|
0 |
Hypotension |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Raynaud's phenomenon |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Superior vena cava occlusion |
0/2119 (0.00%)
|
0 |
1/2114 (0.05%)
|
1 |
Temporal arteritis |
1/2119 (0.05%)
|
1 |
0/2114 (0.00%)
|
0 |
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
3%
|
|
Usual Care
|
FF/VI
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
0/2119 (0.00%)
|
|
0/2114 (0.00%)
|
|