Time Frame |
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV), at least 30 days following the last dose of study treatment . All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
LDK378 50 mg
|
LDK378 100 mg
|
LDK378 200 mg
|
LDK378 300 mg
|
LDK378 400 mg
|
LDK378 500 mg
|
LDK378 600 mg
|
LDK378 700 mg
|
LDK378 750 mg
|
All Participants
|
Arm/Group Description |
Participants receiving 50 mg of LDK...
|
Participants receiving 100 mg of LD...
|
Participants receiving 200 mg of LD...
|
Participants receiving 300 mg of LD...
|
Participants receiving 400 mg of LD...
|
Participants receiving 500 mg of LD...
|
Participants receiving 600 mg of LD...
|
Participants receiving 700 mg of LD...
|
Participants receiving 750 mg of LD...
|
All participants enrolled in the st...
|
Arm/Group Description |
Participants receiving 50 mg of LDK378
|
Participants receiving 100 mg of LDK378
|
Participants receiving 200 mg of LDK378
|
Participants receiving 300 mg of LDK378
|
Participants receiving 400 mg of LDK378
|
Participants receiving 500 mg of LDK378
|
Participants receiving 600 mg of LDK378
|
Participants receiving 700 mg of LDK378
|
Participants receiving 750 mg of LDK378.
|
All participants enrolled in the study
|
|
|
LDK378 50 mg
|
LDK378 100 mg
|
LDK378 200 mg
|
LDK378 300 mg
|
LDK378 400 mg
|
LDK378 500 mg
|
LDK378 600 mg
|
LDK378 700 mg
|
LDK378 750 mg
|
All Participants
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
--/-- |
|
|
LDK378 50 mg
|
LDK378 100 mg
|
LDK378 200 mg
|
LDK378 300 mg
|
LDK378 400 mg
|
LDK378 500 mg
|
LDK378 600 mg
|
LDK378 700 mg
|
LDK378 750 mg
|
All Participants
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
0/2 (0.00%) |
1/2 (50.00%) |
1/3 (33.33%) |
1/3 (33.33%) |
7/14 (50.00%) |
4/10 (40.00%) |
7/10 (70.00%) |
3/5 (60.00%) |
145/255 (56.86%) |
169/304 (55.59%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
|
Anaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Febrile Neutropenia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Cardiac disorders |
|
|
|
|
|
|
|
|
|
|
Acute Myocardial Infarction |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Angina Pectoris |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Atrial Fibrillation |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Cardiac Failure Congestive |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Cardiac Tamponade |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Cardio-Respiratory Arrest |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Pericardial Effusion |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
6/255 (2.35%) |
7/304 (2.30%) |
Pericarditis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
5/255 (1.96%) |
5/304 (1.64%) |
Stress Cardiomyopathy |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Supraventricular Extrasystoles |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Congenital, familial and genetic disorders |
|
|
|
|
|
|
|
|
|
|
Atrial Septal Defect |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
|
|
|
Hearing Impaired |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Eye disorders |
|
|
|
|
|
|
|
|
|
|
Cataract |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Diabetic Retinopathy |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
|
Abdominal Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Abdominal Pain Upper |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Constipation |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Diarrhoea |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
3/304 (0.99%) |
Dyspepsia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Dysphagia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Gastric Ulcer |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Gastritis Haemorrhagic |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Ileus |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Intestinal Perforation |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Intra-Abdominal Haemorrhage |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Nausea |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
6/255 (2.35%) |
6/304 (1.97%) |
Oesophagitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Pancreatitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Stomatitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Subileus |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Upper Gastrointestinal Haemorrhage |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Vomiting |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
6/304 (1.97%) |
General disorders |
|
|
|
|
|
|
|
|
|
|
Asthenia |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Chest Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Drug Withdrawal Syndrome |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Fatigue |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Gait Disturbance |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
General Physical Health Deterioration |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
6/255 (2.35%) |
6/304 (1.97%) |
Multi-Organ Failure |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Non-Cardiac Chest Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
4/255 (1.57%) |
4/304 (1.32%) |
Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Pyrexia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
4/255 (1.57%) |
4/304 (1.32%) |
Hepatobiliary disorders |
|
|
|
|
|
|
|
|
|
|
Bile Duct Obstruction |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Cholecystitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Drug-Induced Liver Injury |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Gallbladder Fistula |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Gallbladder Oedema |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Gallbladder Perforation |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Hepatitis Cholestatic |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Infections and infestations |
|
|
|
|
|
|
|
|
|
|
Appendicitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Appendicitis Perforated |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Bacterial Sepsis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Bronchitis |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Cellulitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Cranial Nerve Infection |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Diverticulitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Empyema |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Gastroenteritis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Infection |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Ludwig Angina |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Lung Infection |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Neutropenic Sepsis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Oral Candidiasis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Peritonitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Pneumonia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
19/255 (7.45%) |
20/304 (6.58%) |
Pneumonia Bacterial |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Pulmonary Tuberculosis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Respiratory Tract Infection |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Sepsis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
3/304 (0.99%) |
Septic Shock |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Urinary Tract Infection |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
|
Compression Fracture |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Eye Injury |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Facial Bones Fracture |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Pelvic Fracture |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Spinal Fracture |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Toxicity To Various Agents |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Upper Limb Fracture |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Investigations |
|
|
|
|
|
|
|
|
|
|
Alanine Aminotransferase Increased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
5/255 (1.96%) |
6/304 (1.97%) |
Amylase Increased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Aspartate Aminotransferase Increased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
4/304 (1.32%) |
Blood Creatinine Increased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Blood Urea Increased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Ejection Fraction Decreased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Lipase Increased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Oxygen Saturation Decreased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Platelet Count Decreased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Transaminases Increased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
|
Decreased Appetite |
0/2 (0.00%) |
1/2 (50.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Dehydration |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
4/255 (1.57%) |
5/304 (1.64%) |
Diabetic Ketoacidosis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Hypercalcaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Hyperglycaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
6/255 (2.35%) |
6/304 (1.97%) |
Hyperkalaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Hyperuricaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Hypomagnesaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Hyponatraemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
|
Arthralgia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Back Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Bone Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Fracture Pain |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Muscular Weakness |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Musculoskeletal Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Neck Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Tendon Disorder |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
|
Basal Cell Carcinoma |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Malignant Neoplasm Of Thorax |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Malignant Pleural Effusion |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Metastases To Central Nervous System |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Metastases To Meninges |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
|
Amnesia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Ataxia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
3/304 (0.99%) |
Brain Oedema |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Cauda Equina Syndrome |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Central Nervous System Necrosis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Cognitive Disorder |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Depressed Level Of Consciousness |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Dizziness |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Dysarthria |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Epilepsy |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Generalised Tonic-Clonic Seizure |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Haemorrhage Intracranial |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Headache |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
5/255 (1.96%) |
5/304 (1.64%) |
Hemiparesis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Hydrocephalus |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Loss Of Consciousness |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Migraine |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Nervous System Disorder |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Paraplegia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Seizure |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
16/255 (6.27%) |
18/304 (5.92%) |
Somnolence |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Speech Disorder |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Spinal Cord Compression |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Syncope |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Toxic Encephalopathy |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
|
Anxiety |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Confusional State |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Mental Disorder |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Mental Status Changes |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
|
Acute Kidney Injury |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Azotaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Calculus Ureteric |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Renal Failure |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
|
|
|
Pelvic Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
|
Acute Respiratory Failure |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Atelectasis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Chronic Obstructive Pulmonary Disease |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Dyspnoea |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
15/255 (5.88%) |
16/304 (5.26%) |
Epistaxis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Haemoptysis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Hiccups |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Hypoxia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Interstitial Lung Disease |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Lung Infiltration |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Obstructive Airways Disorder |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Pleural Effusion |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
3/304 (0.99%) |
Pleuritic Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Pneumonia Aspiration |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
2/304 (0.66%) |
Pneumonitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
9/255 (3.53%) |
9/304 (2.96%) |
Pneumothorax |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
4/255 (1.57%) |
5/304 (1.64%) |
Pulmonary Embolism |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
4/304 (1.32%) |
Respiratory Distress |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
0/255 (0.00%) |
2/304 (0.66%) |
Respiratory Failure |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
1/3 (33.33%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
6/255 (2.35%) |
8/304 (2.63%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
|
|
Pruritus |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Vascular disorders |
|
|
|
|
|
|
|
|
|
|
Deep Vein Thrombosis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Embolism |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Thrombophlebitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
1/304 (0.33%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA (19.0)
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
LDK378 50 mg
|
LDK378 100 mg
|
LDK378 200 mg
|
LDK378 300 mg
|
LDK378 400 mg
|
LDK378 500 mg
|
LDK378 600 mg
|
LDK378 700 mg
|
LDK378 750 mg
|
All Participants
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
2/2 (100.00%) |
2/2 (100.00%) |
3/3 (100.00%) |
3/3 (100.00%) |
14/14 (100.00%) |
10/10 (100.00%) |
10/10 (100.00%) |
5/5 (100.00%) |
254/255 (99.61%) |
303/304 (99.67%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
|
Anaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
1/3 (33.33%) |
2/14 (14.29%) |
2/10 (20.00%) |
3/10 (30.00%) |
0/5 (0.00%) |
32/255 (12.55%) |
40/304 (13.16%) |
Leukocytosis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Cardiac disorders |
|
|
|
|
|
|
|
|
|
|
Arrhythmia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Atrial Fibrillation |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Bradycardia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
5/255 (1.96%) |
6/304 (1.97%) |
Sinus Bradycardia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
4/255 (1.57%) |
5/304 (1.64%) |
Sinus Tachycardia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
1/3 (33.33%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
3/304 (0.99%) |
Tachycardia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
6/255 (2.35%) |
7/304 (2.30%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
|
|
|
Tinnitus |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
7/255 (2.75%) |
8/304 (2.63%) |
Vertigo |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
7/255 (2.75%) |
8/304 (2.63%) |
Eye disorders |
|
|
|
|
|
|
|
|
|
|
Blepharospasm |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
4/255 (1.57%) |
5/304 (1.64%) |
Diplopia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Eyelid Ptosis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Photopsia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
2/14 (14.29%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
5/304 (1.64%) |
Visual Impairment |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
17/255 (6.67%) |
17/304 (5.59%) |
Vitreous Floaters |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
1/255 (0.39%) |
3/304 (0.99%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
|
Abdominal Discomfort |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
18/255 (7.06%) |
19/304 (6.25%) |
Abdominal Distension |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
2/10 (20.00%) |
0/5 (0.00%) |
9/255 (3.53%) |
13/304 (4.28%) |
Abdominal Pain |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
1/3 (33.33%) |
1/14 (7.14%) |
3/10 (30.00%) |
2/10 (20.00%) |
1/5 (20.00%) |
102/255 (40.00%) |
111/304 (36.51%) |
Abdominal Pain Lower |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
4/304 (1.32%) |
Abdominal Pain Upper |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
2/14 (14.29%) |
1/10 (10.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
64/255 (25.10%) |
68/304 (22.37%) |
Ascites |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Constipation |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
3/14 (21.43%) |
3/10 (30.00%) |
4/10 (40.00%) |
2/5 (40.00%) |
90/255 (35.29%) |
103/304 (33.88%) |
Dental Caries |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
4/255 (1.57%) |
5/304 (1.64%) |
Diarrhoea |
0/2 (0.00%) |
0/2 (0.00%) |
2/3 (66.67%) |
1/3 (33.33%) |
9/14 (64.29%) |
7/10 (70.00%) |
8/10 (80.00%) |
4/5 (80.00%) |
221/255 (86.67%) |
252/304 (82.89%) |
Dyspepsia |
1/2 (50.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
2/10 (20.00%) |
4/10 (40.00%) |
1/5 (20.00%) |
35/255 (13.73%) |
43/304 (14.14%) |
Dysphagia |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
2/10 (20.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
7/255 (2.75%) |
10/304 (3.29%) |
Flatulence |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
11/255 (4.31%) |
12/304 (3.95%) |
Gastrointestinal Disorder |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Gastrointestinal Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Gastrooesophageal Reflux Disease |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
20/255 (7.84%) |
22/304 (7.24%) |
Haemorrhoids |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
5/304 (1.64%) |
Melaena |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Mouth Swelling |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Nausea |
0/2 (0.00%) |
1/2 (50.00%) |
2/3 (66.67%) |
2/3 (66.67%) |
10/14 (71.43%) |
9/10 (90.00%) |
10/10 (100.00%) |
5/5 (100.00%) |
215/255 (84.31%) |
254/304 (83.55%) |
Stomatitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
17/255 (6.67%) |
18/304 (5.92%) |
Toothache |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
5/304 (1.64%) |
Vomiting |
0/2 (0.00%) |
1/2 (50.00%) |
3/3 (100.00%) |
1/3 (33.33%) |
8/14 (57.14%) |
5/10 (50.00%) |
8/10 (80.00%) |
4/5 (80.00%) |
159/255 (62.35%) |
189/304 (62.17%) |
General disorders |
|
|
|
|
|
|
|
|
|
|
Asthenia |
0/2 (0.00%) |
1/2 (50.00%) |
1/3 (33.33%) |
1/3 (33.33%) |
2/14 (14.29%) |
1/10 (10.00%) |
3/10 (30.00%) |
3/5 (60.00%) |
58/255 (22.75%) |
70/304 (23.03%) |
Axillary Pain |
0/2 (0.00%) |
1/2 (50.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Chest Discomfort |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
1/10 (10.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
23/255 (9.02%) |
26/304 (8.55%) |
Chest Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
18/255 (7.06%) |
19/304 (6.25%) |
Chills |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
14/255 (5.49%) |
15/304 (4.93%) |
Facial Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Fatigue |
1/2 (50.00%) |
1/2 (50.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
5/14 (35.71%) |
4/10 (40.00%) |
8/10 (80.00%) |
1/5 (20.00%) |
111/255 (43.53%) |
132/304 (43.42%) |
Gait Disturbance |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
10/255 (3.92%) |
11/304 (3.62%) |
Hunger |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Inflammation |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Influenza Like Illness |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
2/14 (14.29%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
6/255 (2.35%) |
8/304 (2.63%) |
Local Swelling |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Non-Cardiac Chest Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
1/5 (20.00%) |
28/255 (10.98%) |
30/304 (9.87%) |
Oedema |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
4/255 (1.57%) |
6/304 (1.97%) |
Oedema Peripheral |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
1/10 (10.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
32/255 (12.55%) |
35/304 (11.51%) |
Pain |
1/2 (50.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
18/255 (7.06%) |
21/304 (6.91%) |
Pyrexia |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
1/10 (10.00%) |
1/5 (20.00%) |
46/255 (18.04%) |
50/304 (16.45%) |
Immune system disorders |
|
|
|
|
|
|
|
|
|
|
Seasonal Allergy |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
6/255 (2.35%) |
7/304 (2.30%) |
Infections and infestations |
|
|
|
|
|
|
|
|
|
|
Bacterial Disease Carrier |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Bronchitis |
1/2 (50.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
7/255 (2.75%) |
9/304 (2.96%) |
Clostridium Difficile Infection |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Cystitis |
1/2 (50.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
4/255 (1.57%) |
5/304 (1.64%) |
Gingivitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Herpes Dermatitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Influenza |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
20/255 (7.84%) |
22/304 (7.24%) |
Nasopharyngitis |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
23/255 (9.02%) |
26/304 (8.55%) |
Oral Infection |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Pneumonia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
13/255 (5.10%) |
14/304 (4.61%) |
Respiratory Tract Infection |
0/2 (0.00%) |
1/2 (50.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
6/255 (2.35%) |
8/304 (2.63%) |
Tonsillitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Tooth Abscess |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Upper Respiratory Tract Infection |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
3/14 (21.43%) |
2/10 (20.00%) |
1/10 (10.00%) |
1/5 (20.00%) |
32/255 (12.55%) |
40/304 (13.16%) |
Urinary Tract Infection |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
2/10 (20.00%) |
0/5 (0.00%) |
18/255 (7.06%) |
21/304 (6.91%) |
Vaginal Infection |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Vulvovaginal Candidiasis |
1/2 (50.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
|
Burns First Degree |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Fall |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
8/255 (3.14%) |
10/304 (3.29%) |
Ligament Sprain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Spinal Fracture |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Tendon Rupture |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Investigations |
|
|
|
|
|
|
|
|
|
|
Alanine Aminotransferase Increased |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
2/14 (14.29%) |
3/10 (30.00%) |
3/10 (30.00%) |
4/5 (80.00%) |
122/255 (47.84%) |
135/304 (44.41%) |
Amylase Increased |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
3/10 (30.00%) |
0/5 (0.00%) |
23/255 (9.02%) |
28/304 (9.21%) |
Aspartate Aminotransferase Increased |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
3/14 (21.43%) |
2/10 (20.00%) |
3/10 (30.00%) |
3/5 (60.00%) |
91/255 (35.69%) |
103/304 (33.88%) |
Blood Alkaline Phosphatase Increased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
2/10 (20.00%) |
1/5 (20.00%) |
48/255 (18.82%) |
52/304 (17.11%) |
Blood Creatinine Increased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
47/255 (18.43%) |
49/304 (16.12%) |
Blood Lactate Dehydrogenase Increased |
1/2 (50.00%) |
1/2 (50.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
5/255 (1.96%) |
7/304 (2.30%) |
Blood Magnesium Decreased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
2/14 (14.29%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
2/304 (0.66%) |
C-Reactive Protein Increased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
10/255 (3.92%) |
11/304 (3.62%) |
Electrocardiogram Qt Prolonged |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
2/10 (20.00%) |
1/5 (20.00%) |
12/255 (4.71%) |
15/304 (4.93%) |
Gamma-Glutamyltransferase Increased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
14/255 (5.49%) |
14/304 (4.61%) |
Haemoglobin Decreased |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Lipase Increased |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
1/3 (33.33%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
35/255 (13.73%) |
38/304 (12.50%) |
Protein Total Decreased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Transaminases Increased |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
2/14 (14.29%) |
0/10 (0.00%) |
2/10 (20.00%) |
0/5 (0.00%) |
10/255 (3.92%) |
14/304 (4.61%) |
Weight Decreased |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
5/14 (35.71%) |
1/10 (10.00%) |
1/10 (10.00%) |
3/5 (60.00%) |
51/255 (20.00%) |
62/304 (20.39%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
|
Decreased Appetite |
0/2 (0.00%) |
1/2 (50.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
3/10 (30.00%) |
4/10 (40.00%) |
3/5 (60.00%) |
99/255 (38.82%) |
111/304 (36.51%) |
Dehydration |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
17/255 (6.67%) |
18/304 (5.92%) |
Electrolyte Imbalance |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Hypercalcaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
4/304 (1.32%) |
Hypercholesterolaemia |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Hyperglycaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
23/255 (9.02%) |
24/304 (7.89%) |
Hyperkalaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
6/255 (2.35%) |
7/304 (2.30%) |
Hyperuricaemia |
0/2 (0.00%) |
0/2 (0.00%) |
2/3 (66.67%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
8/255 (3.14%) |
10/304 (3.29%) |
Hypoalbuminaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
14/255 (5.49%) |
15/304 (4.93%) |
Hypocalcaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
11/255 (4.31%) |
12/304 (3.95%) |
Hypoglycaemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Hypokalaemia |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
2/14 (14.29%) |
1/10 (10.00%) |
2/10 (20.00%) |
1/5 (20.00%) |
34/255 (13.33%) |
41/304 (13.49%) |
Hypomagnesaemia |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
1/14 (7.14%) |
1/10 (10.00%) |
2/10 (20.00%) |
0/5 (0.00%) |
25/255 (9.80%) |
30/304 (9.87%) |
Hyponatraemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
1/10 (10.00%) |
2/10 (20.00%) |
0/5 (0.00%) |
19/255 (7.45%) |
23/304 (7.57%) |
Hypophosphataemia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
1/10 (10.00%) |
2/10 (20.00%) |
0/5 (0.00%) |
19/255 (7.45%) |
23/304 (7.57%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
|
Arthralgia |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
2/14 (14.29%) |
1/10 (10.00%) |
1/10 (10.00%) |
2/5 (40.00%) |
31/255 (12.16%) |
38/304 (12.50%) |
Back Pain |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
1/3 (33.33%) |
3/14 (21.43%) |
1/10 (10.00%) |
4/10 (40.00%) |
1/5 (20.00%) |
56/255 (21.96%) |
67/304 (22.04%) |
Bone Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
8/255 (3.14%) |
9/304 (2.96%) |
Bursitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Coccydynia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Flank Pain |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
14/255 (5.49%) |
15/304 (4.93%) |
Fracture Pain |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Muscle Atrophy |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Muscle Spasms |
1/2 (50.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
1/5 (20.00%) |
24/255 (9.41%) |
27/304 (8.88%) |
Muscular Weakness |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
2/14 (14.29%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
17/255 (6.67%) |
19/304 (6.25%) |
Musculoskeletal Chest Pain |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
32/255 (12.55%) |
33/304 (10.86%) |
Musculoskeletal Discomfort |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
5/255 (1.96%) |
6/304 (1.97%) |
Musculoskeletal Pain |
0/2 (0.00%) |
0/2 (0.00%) |
2/3 (66.67%) |
0/3 (0.00%) |
2/14 (14.29%) |
2/10 (20.00%) |
1/10 (10.00%) |
1/5 (20.00%) |
40/255 (15.69%) |
48/304 (15.79%) |
Myalgia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
1/10 (10.00%) |
2/5 (40.00%) |
12/255 (4.71%) |
16/304 (5.26%) |
Neck Pain |
0/2 (0.00%) |
1/2 (50.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
16/255 (6.27%) |
17/304 (5.59%) |
Osteonecrosis Of Jaw |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Osteoporosis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Pain In Extremity |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
1/3 (33.33%) |
0/14 (0.00%) |
1/10 (10.00%) |
3/10 (30.00%) |
1/5 (20.00%) |
23/255 (9.02%) |
29/304 (9.54%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
|
Melanocytic Naevus |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
|
Akathisia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Complex Partial Seizures |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Dizziness |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
2/14 (14.29%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
38/255 (14.90%) |
42/304 (13.82%) |
Dysgeusia |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
2/5 (40.00%) |
19/255 (7.45%) |
23/304 (7.57%) |
Headache |
1/2 (50.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
2/14 (14.29%) |
0/10 (0.00%) |
3/10 (30.00%) |
1/5 (20.00%) |
66/255 (25.88%) |
74/304 (24.34%) |
Hypoaesthesia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
9/255 (3.53%) |
10/304 (3.29%) |
Migraine |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
4/255 (1.57%) |
5/304 (1.64%) |
Neuralgia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Neuropathy Peripheral |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
7/255 (2.75%) |
8/304 (2.63%) |
Paraesthesia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
2/10 (20.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
23/255 (9.02%) |
26/304 (8.55%) |
Peripheral Motor Neuropathy |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Peripheral Sensory Neuropathy |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
4/304 (1.32%) |
Sensory Loss |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Sinus Headache |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Tremor |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
20/255 (7.84%) |
20/304 (6.58%) |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
|
Anxiety |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
24/255 (9.41%) |
25/304 (8.22%) |
Delirium |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
2/304 (0.66%) |
Depression |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
16/255 (6.27%) |
17/304 (5.59%) |
Insomnia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
3/10 (30.00%) |
2/10 (20.00%) |
1/5 (20.00%) |
45/255 (17.65%) |
52/304 (17.11%) |
Mood Altered |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
|
Dysuria |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
6/255 (2.35%) |
7/304 (2.30%) |
Haematuria |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
4/304 (1.32%) |
Renal Failure |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Urinary Incontinence |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
5/255 (1.96%) |
6/304 (1.97%) |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
|
|
|
Breast Oedema |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Retracted Nipple |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Vaginal Odour |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
|
Bronchospasm |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Cough |
0/2 (0.00%) |
0/2 (0.00%) |
2/3 (66.67%) |
0/3 (0.00%) |
3/14 (21.43%) |
3/10 (30.00%) |
3/10 (30.00%) |
0/5 (0.00%) |
83/255 (32.55%) |
94/304 (30.92%) |
Dysphonia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
14/255 (5.49%) |
16/304 (5.26%) |
Dyspnoea |
2/2 (100.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
1/3 (33.33%) |
2/14 (14.29%) |
5/10 (50.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
61/255 (23.92%) |
72/304 (23.68%) |
Dyspnoea Exertional |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
2/10 (20.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
16/255 (6.27%) |
18/304 (5.92%) |
Epistaxis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
4/304 (1.32%) |
Haemoptysis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
1/5 (20.00%) |
11/255 (4.31%) |
13/304 (4.28%) |
Hiccups |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
4/304 (1.32%) |
Nasal Congestion |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
5/255 (1.96%) |
6/304 (1.97%) |
Oropharyngeal Pain |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
2/10 (20.00%) |
2/5 (40.00%) |
17/255 (6.67%) |
23/304 (7.57%) |
Pneumonitis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Productive Cough |
1/2 (50.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
33/255 (12.94%) |
36/304 (11.84%) |
Pulmonary Embolism |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Rhinorrhoea |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
18/255 (7.06%) |
18/304 (5.92%) |
Sinus Congestion |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
5/255 (1.96%) |
6/304 (1.97%) |
Tachypnoea |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
1/255 (0.39%) |
2/304 (0.66%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
|
|
Acne |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
4/255 (1.57%) |
5/304 (1.64%) |
Alopecia |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
13/255 (5.10%) |
14/304 (4.61%) |
Dermatitis Acneiform |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
10/255 (3.92%) |
11/304 (3.62%) |
Dry Skin |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
18/255 (7.06%) |
20/304 (6.58%) |
Erythema |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
5/255 (1.96%) |
6/304 (1.97%) |
Pigmentation Disorder |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
1/10 (10.00%) |
1/5 (20.00%) |
0/255 (0.00%) |
2/304 (0.66%) |
Pruritus |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
19/255 (7.45%) |
22/304 (7.24%) |
Rash |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
1/14 (7.14%) |
1/10 (10.00%) |
1/10 (10.00%) |
1/5 (20.00%) |
39/255 (15.29%) |
44/304 (14.47%) |
Rash Maculo-Papular |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
3/255 (1.18%) |
4/304 (1.32%) |
Rash Pruritic |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
1/14 (7.14%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
2/255 (0.78%) |
3/304 (0.99%) |
Scab |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Vascular disorders |
|
|
|
|
|
|
|
|
|
|
Haemodynamic Instability |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Hot Flush |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
5/255 (1.96%) |
6/304 (1.97%) |
Hypertension |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
1/5 (20.00%) |
12/255 (4.71%) |
14/304 (4.61%) |
Hypotension |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
0/3 (0.00%) |
0/14 (0.00%) |
1/10 (10.00%) |
1/10 (10.00%) |
0/5 (0.00%) |
8/255 (3.14%) |
10/304 (3.29%) |
Jugular Vein Thrombosis |
0/2 (0.00%) |
0/2 (0.00%) |
0/3 (0.00%) |
1/3 (33.33%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Lymphoedema |
0/2 (0.00%) |
0/2 (0.00%) |
1/3 (33.33%) |
0/3 (0.00%) |
0/14 (0.00%) |
0/10 (0.00%) |
0/10 (0.00%) |
0/5 (0.00%) |
0/255 (0.00%) |
1/304 (0.33%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA (19.0)
|