Time Frame |
SAEs and Other AEs: From first dose up to 30 days after last dose of the study drug (Up to approximately 49 months); All-Cause Mortality: Up to approximately 8 years
|
Adverse Event Reporting Description |
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Arm/Group Title
|
Cohort A: CP-CML R-I
|
Cohort B: CP-CML With T315I Mutation
|
Cohort C: AP-CML R-I
|
Cohort D: AP-CML With T315I Mutation
|
Cohort E: BP-CML/Ph+ ALL R-I
|
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
|
Unassigned AP/CP-CML
|
Arm/Group Description |
CP-CML participants R-I to dasatini...
|
CP-CML participants who had T315I m...
|
AP-CML R-I to dasatinib or nilotini...
|
AP-CML participants who had T315I m...
|
BP-CML or Ph+ ALL R-I to dasatinib ...
|
BP-CML or Ph+ ALL participants who ...
|
Participants who were not assigned ...
|
Arm/Group Description |
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
|
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
|
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
|
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
|
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
|
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
|
Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not R-I to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
|
|
|
Cohort A: CP-CML R-I
|
Cohort B: CP-CML With T315I Mutation
|
Cohort C: AP-CML R-I
|
Cohort D: AP-CML With T315I Mutation
|
Cohort E: BP-CML/Ph+ ALL R-I
|
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
|
Unassigned AP/CP-CML
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
41/203 (20.20%) |
18/64 (28.13%) |
30/65 (46.15%) |
9/18 (50.00%) |
40/48 (83.33%) |
39/46 (84.78%) |
2/5 (40.00%) |
|
|
Cohort A: CP-CML R-I
|
Cohort B: CP-CML With T315I Mutation
|
Cohort C: AP-CML R-I
|
Cohort D: AP-CML With T315I Mutation
|
Cohort E: BP-CML/Ph+ ALL R-I
|
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
|
Unassigned AP/CP-CML
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
132/203 (65.02%) |
39/64 (60.94%) |
44/65 (67.69%) |
13/18 (72.22%) |
41/48 (85.42%) |
37/46 (80.43%) |
3/5 (60.00%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
Anaemia |
7/203 (3.45%) |
0/64 (0.00%) |
4/65 (6.15%) |
0/18 (0.00%) |
2/48 (4.17%) |
2/46 (4.35%) |
0/5 (0.00%) |
Febrile neutropenia |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
5/48 (10.42%) |
5/46 (10.87%) |
0/5 (0.00%) |
Pancytopenia |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
2/48 (4.17%) |
1/46 (2.17%) |
0/5 (0.00%) |
Splenic infarction |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hyperviscosity syndrome |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hyperleukocytosis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Lymphadenopathy |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Neutropenia |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
2/46 (4.35%) |
0/5 (0.00%) |
Thrombocytopenia |
1/203 (0.49%) |
1/64 (1.56%) |
4/65 (6.15%) |
0/18 (0.00%) |
2/48 (4.17%) |
1/46 (2.17%) |
0/5 (0.00%) |
Cardiac disorders |
|
|
|
|
|
|
|
Atrial fibrillation |
11/203 (5.42%) |
4/64 (6.25%) |
0/65 (0.00%) |
0/18 (0.00%) |
3/48 (6.25%) |
2/46 (4.35%) |
0/5 (0.00%) |
Cardiac failure congestive |
5/203 (2.46%) |
3/64 (4.69%) |
1/65 (1.54%) |
0/18 (0.00%) |
1/48 (2.08%) |
1/46 (2.17%) |
0/5 (0.00%) |
Coronary artery disease |
4/203 (1.97%) |
6/64 (9.38%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Acute myocardial infarction |
2/203 (0.99%) |
1/64 (1.56%) |
1/65 (1.54%) |
2/18 (11.11%) |
2/48 (4.17%) |
0/46 (0.00%) |
0/5 (0.00%) |
Angina pectoris |
10/203 (4.93%) |
4/64 (6.25%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cardiac arrest |
2/203 (0.99%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Coronary artery stenosis |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Atrial tachycardia |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pericardial effusion |
3/203 (1.48%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
1/48 (2.08%) |
1/46 (2.17%) |
0/5 (0.00%) |
Sinus tachycardia |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Acute coronary syndrome |
3/203 (1.48%) |
3/64 (4.69%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Cardiopulmonary failure |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Cardiac failure |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
3/48 (6.25%) |
0/46 (0.00%) |
1/5 (20.00%) |
Atrial flutter |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Atrioventricular block complete |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cardiac tamponade |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Cardiogenic shock |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pericarditis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Right ventricular failure |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Tachycardia |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Coronary artery occlusion |
2/203 (0.99%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Acute left ventricular failure |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Angina unstable |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Aortic valve stenosis |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Arrhythmia supraventricular |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Arteriosclerosis coronary artery |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Arteriospasm coronary |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Bradycardia |
0/203 (0.00%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cardiac Discomfort |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cardiac failure acute |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cardio-respiratory arrest |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Congestive cardiomyopathy |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Dressler's syndrome |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Ischaemic cardiomyopathy |
0/203 (0.00%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Left ventricular dysfunction |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Mitral valve incompetence |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Sinus node dysfunction |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Ventricular tachycardia |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cardiac failure chronic |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Bundle branch block right |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Left ventricular failure |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Myocardial infarction |
3/203 (1.48%) |
4/64 (6.25%) |
2/65 (3.08%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
Vertigo positional |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Vertigo |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Endocrine disorders |
|
|
|
|
|
|
|
Thyroid mass |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Eye disorders |
|
|
|
|
|
|
|
Retinal vein occlusion |
2/203 (0.99%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cataract |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cystoid macular oedema |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Retinal artery occlusion |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Retinal vein thrombosis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Ulcerative keratitis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Vision blurred |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Macular fibrosis |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
Pancreatitis |
10/203 (4.93%) |
4/64 (6.25%) |
3/65 (4.62%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Abdominal pain |
7/203 (3.45%) |
1/64 (1.56%) |
4/65 (6.15%) |
1/18 (5.56%) |
4/48 (8.33%) |
1/46 (2.17%) |
0/5 (0.00%) |
Constipation |
3/203 (1.48%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Diarrhoea |
1/203 (0.49%) |
1/64 (1.56%) |
1/65 (1.54%) |
1/18 (5.56%) |
1/48 (2.08%) |
1/46 (2.17%) |
0/5 (0.00%) |
Gastritis |
2/203 (0.99%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Vomiting |
0/203 (0.00%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
2/48 (4.17%) |
0/46 (0.00%) |
0/5 (0.00%) |
Colitis |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Hiatus hernia |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Ileus |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Nausea |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Oesophagitis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Haemorrhoidal haemorrhage |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Ascites |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Rectal haemorrhage |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Retroperitoneal haematoma |
0/203 (0.00%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gastrointestinal haemorrhage |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
2/46 (4.35%) |
1/5 (20.00%) |
Abdominal distension |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Acute abdomen |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Dysphagia |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gastric haemorrhage |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gastritis haemorrhagic |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Stomatitis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Appendicitis Noninfective |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Colitis Ischaemic |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Faecaloma |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Fistula of small intestine |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gastric ulcer haemorrhage |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Inguinal hernia |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Large intestinal obstruction |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Small intestinal obstruction |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Upper gastrointestinal haemorrhage |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gastrooesophageal reflux disease |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Peritoneal haemorrhage |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Mesenteric arterial occlusion |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Abdominal pain upper |
2/203 (0.99%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pancreatitis acute |
5/203 (2.46%) |
1/64 (1.56%) |
2/65 (3.08%) |
0/18 (0.00%) |
2/48 (4.17%) |
0/46 (0.00%) |
0/5 (0.00%) |
General disorders |
|
|
|
|
|
|
|
Pyrexia |
5/203 (2.46%) |
3/64 (4.69%) |
5/65 (7.69%) |
2/18 (11.11%) |
2/48 (4.17%) |
2/46 (4.35%) |
1/5 (20.00%) |
Non-cardiac chest pain |
4/203 (1.97%) |
1/64 (1.56%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Asthenia |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Chest pain |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Chills |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
2/48 (4.17%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pain |
1/203 (0.49%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Systemic inflammatory response syndrome |
0/203 (0.00%) |
2/64 (3.13%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Implant site pain |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Impaired healing |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gait disturbance |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Oedema peripheral |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Vascular stent occlusion |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Fatigue |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Multiple organ dysfunction syndrome |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
1/46 (2.17%) |
0/5 (0.00%) |
Hepatobiliary disorders |
|
|
|
|
|
|
|
Bile duct stone |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cholangitis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cholelithiasis |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cholecystitis |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Cholecystitis acute |
1/203 (0.49%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Portal vein thrombosis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Non-alcoholic steatohepatitis |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Venoocclusive liver disease |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Biliary dilatation |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gallbladder obstruction |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hyperbilirubinaemia |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Immune system disorders |
|
|
|
|
|
|
|
Hypersensitivity |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Graft versus host disease in skin |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Anaphylactic reaction |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Anaphylactoid reaction |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Drug hypersensitivity |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
|
Pneumonia |
10/203 (4.93%) |
5/64 (7.81%) |
8/65 (12.31%) |
1/18 (5.56%) |
4/48 (8.33%) |
5/46 (10.87%) |
0/5 (0.00%) |
Cellulitis |
4/203 (1.97%) |
1/64 (1.56%) |
2/65 (3.08%) |
1/18 (5.56%) |
2/48 (4.17%) |
0/46 (0.00%) |
0/5 (0.00%) |
Sepsis |
2/203 (0.99%) |
1/64 (1.56%) |
2/65 (3.08%) |
1/18 (5.56%) |
2/48 (4.17%) |
2/46 (4.35%) |
1/5 (20.00%) |
Upper respiratory tract infection |
2/203 (0.99%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Urinary tract infection |
5/203 (2.46%) |
2/64 (3.13%) |
0/65 (0.00%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Bacterial infection |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Bronchitis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Diverticulitis |
2/203 (0.99%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Herpes oesophagitis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Osteomyelitis |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Respiratory syncytial virus infection |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Wound infection |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Bacteraemia |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Appendicitis |
0/203 (0.00%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Breast cellulitis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Clostridium difficile colitis |
3/203 (1.48%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
2/48 (4.17%) |
0/46 (0.00%) |
0/5 (0.00%) |
Infection |
0/203 (0.00%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Localised infection |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Lung infection |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pharyngitis streptococcal |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pneumonia fungal |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pulmonary tuberculosis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Respiratory tract infection |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Septic shock |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
2/46 (4.35%) |
0/5 (0.00%) |
Splenic abscess |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Klebsiella sepsis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
2/46 (4.35%) |
0/5 (0.00%) |
Catheter site cellulitis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gastroenteritis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
2/48 (4.17%) |
0/46 (0.00%) |
0/5 (0.00%) |
Haematoma infection |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Otitis externa |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pneumonia respiratory syncytial viral |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Post procedural infection |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Abdominal sepsis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Arthritis bacterial |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Arthritis viral |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cholecystitis infective |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Clostridium difficile infection |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Genital infection bacterial |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Otitis media chronic |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Peritonitis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pneumonia mycoplasmal |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pyelonephritis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pyelonephritis acute |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Systemic infection |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Viral infection |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Wound infection staphylococcal |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pneumonia staphylococcal |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gangrene |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gastroenteritis norovirus |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Kidney infection |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Urosepsis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Oesophageal candidiasis |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Atypical pneumonia |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Device related sepsis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Infectious colitis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pneumonia influenzal |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Postoperative wound infection |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Staphylococcal bacteraemia |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Pneumocystis jirovecii pneumonia |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
Subarachnoid haemorrhage |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Concussion |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Peripancreatic fluid collection |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Procedural vomiting |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Fall |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Subdural haematoma |
2/203 (0.99%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Post procedural haematoma |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Post procedural haemorrhage |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Procedural pain |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Traumatic intracranial haemorrhage |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Pneumonitis chemical |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Peripheral artery restenosis |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Head injury |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Humerus fracture |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Spinal column injury |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Wound dehiscence |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Wrist fracture |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Investigations |
|
|
|
|
|
|
|
Lipase increased |
4/203 (1.97%) |
3/64 (4.69%) |
1/65 (1.54%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Platelet count decreased |
2/203 (0.99%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Alanine aminotransferase increased |
3/203 (1.48%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Neutrophil count decreased |
2/203 (0.99%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Blood alkaline phosphatase increased |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Ejection fraction decreased |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
2/48 (4.17%) |
1/46 (2.17%) |
0/5 (0.00%) |
Gamma-glutamyltransferase increased |
1/203 (0.49%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Blood bilirubin increased |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Aspartate aminotransferase increased |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Urine analysis abnormal |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hepatic enzyme increased |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
International normalised ratio increased |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Liver function test increased |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Blood potassium increased |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Haemoglobin decreased |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
JC polyomavirus test positive |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
Hyponatraemia |
4/203 (1.97%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Dehydration |
4/203 (1.97%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
2/48 (4.17%) |
1/46 (2.17%) |
0/5 (0.00%) |
Diabetes mellitus |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hyperkalaemia |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Electrolyte imbalance |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Tumour lysis syndrome |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Failure to thrive |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Fluid overload |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Fluid retention |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Hyperuricaemia |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Hypercalcaemia |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hyperglycaemia |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
Arthralgia |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Back pain |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Flank pain |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Myalgia |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Spinal osteoarthritis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Lumbar spinal stenosis |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Bone pain |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
2/48 (4.17%) |
1/46 (2.17%) |
0/5 (0.00%) |
Musculoskeletal pain |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Spinal column stenosis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Osteoarthritis |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Intervertebral disc protrusion |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
Neoplasm progression |
6/203 (2.96%) |
2/64 (3.13%) |
7/65 (10.77%) |
4/18 (22.22%) |
14/48 (29.17%) |
8/46 (17.39%) |
0/5 (0.00%) |
Myelodysplastic syndrome |
3/203 (1.48%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Malignant melanoma |
2/203 (0.99%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Malignant pleural effusion |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Basal cell carcinoma |
1/203 (0.49%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Blast crisis in myelogenous leukaemia |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
1/48 (2.08%) |
1/46 (2.17%) |
0/5 (0.00%) |
Squamous cell carcinoma of skin |
3/203 (1.48%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Chloroma |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Colon cancer |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Skin squamous cell carcinoma metastatic |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Large cell lung cancer recurrent |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Non-hodgkin's lymphoma |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Squamous cell carcinoma |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Vulval cancer |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Central nervous system leukaemia |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Acute lymphocytic leukaemia recurrent |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Pancreatic carcinoma |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Neuroendocrine carcinoma metastatic |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Bowen's disease |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
|
Cerebrovascular accident |
5/203 (2.46%) |
4/64 (6.25%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Headache |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Transient ischaemic attack |
2/203 (0.99%) |
2/64 (3.13%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Ataxia |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cerebral artery stenosis |
0/203 (0.00%) |
2/64 (3.13%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cerebral infarction |
5/203 (2.46%) |
3/64 (4.69%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Haemorrhagic cerebral infarction |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Haemorrhagic transformation stroke |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
IVth nerve paralysis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Spinal cord compression |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cerebellar infarction |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cerebral haemorrhage |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Cerebral ischaemia |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Dizziness |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Migraine |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Somnolence |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Syncope |
3/203 (1.48%) |
1/64 (1.56%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Haemorrhage intracranial |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Brain oedema |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Loss of consciousness |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Paraesthesia |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Status epilepticus |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Dementia |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Facial Paralysis |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Iiird nerve paralysis |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Neuropathy peripheral |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Carotid artery stenosis |
5/203 (2.46%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Cerebrovascular disorder |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Encephalopathy |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hypoaesthesia |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Intracranial aneurysm |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Lacunar infarction |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Memory impairment |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Sciatica |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Seizure |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Carotid artery occlusion |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Product Issues |
|
|
|
|
|
|
|
Device dislocation |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Psychiatric disorders |
|
|
|
|
|
|
|
Confusional state |
3/203 (1.48%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Mental status changes |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
2/46 (4.35%) |
0/5 (0.00%) |
Delirium |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
Renal failure |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Nephrolithiasis |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Acute kidney injury |
2/203 (0.99%) |
2/64 (3.13%) |
2/65 (3.08%) |
0/18 (0.00%) |
3/48 (6.25%) |
0/46 (0.00%) |
0/5 (0.00%) |
Renal artery stenosis |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Haematuria |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Urinary retention |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Dysuria |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
Prostatic obstruction |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Prostatitis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Haemorrhagic ovarian cyst |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Ovarian cyst |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
Dyspnoea |
2/203 (0.99%) |
3/64 (4.69%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Hypoxia |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pneumothorax |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pulmonary embolism |
3/203 (1.48%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
3/48 (6.25%) |
0/46 (0.00%) |
0/5 (0.00%) |
Epistaxis |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pleural effusion |
2/203 (0.99%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
1/48 (2.08%) |
1/46 (2.17%) |
1/5 (20.00%) |
Respiratory failure |
0/203 (0.00%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Chronic obstructive pulmonary disease |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
2/46 (4.35%) |
1/5 (20.00%) |
Dyspnoea exertional |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pleuritic pain |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Pulmonary hypertension |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pneumonitis |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Lung disorder |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
Angioedema |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Erythema |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Erythema multiforme |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hyperkeratosis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Skin ulcer |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Acute febrile neutrophilic dermatosis |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Dermatitis exfoliative generalised |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Skin swelling |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Diabetic foot |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Mucocutaneous haemorrhage |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Rash erythematous |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Rash maculo-papular |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Social circumstances |
|
|
|
|
|
|
|
Immobile |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
|
Hypertension |
11/203 (5.42%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hypotension |
2/203 (0.99%) |
1/64 (1.56%) |
2/65 (3.08%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Deep vein thrombosis |
4/203 (1.97%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
1/46 (2.17%) |
0/5 (0.00%) |
Hot flush |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Peripheral ischaemia |
3/203 (1.48%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Extremity necrosis |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hypertensive crisis |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Embolism venous |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Thrombophlebitis superficial |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Peripheral arterial occlusive disease |
10/203 (4.93%) |
4/64 (6.25%) |
1/65 (1.54%) |
1/18 (5.56%) |
1/48 (2.08%) |
1/46 (2.17%) |
0/5 (0.00%) |
Peripheral artery stenosis |
4/203 (1.97%) |
3/64 (4.69%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Peripheral artery occlusion |
4/203 (1.97%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Peripheral vascular disorder |
2/203 (0.99%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Dry gangrene |
1/203 (0.49%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Aortic arteriosclerosis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Temporal arteritis |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Varicose vein |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Vasculitis |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Coeliac artery occlusion |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Embolism arterial |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Intermittent claudication |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Term from vocabulary, MedDRA version 19.0
Indicates events were collected by systematic assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort E and is not related.
Two treatment-emergent deaths (1-Cohort B, 1-Cohort E) occurred during treatment with ponatinib and are not related.
One treatment-emergent death occurred during treatment with ponatinib in Cohort A and is related.
Four treatment-emergent deaths (2-Cohort A, 1-Cohort B, 1-Cohort F) occurred during treatment with ponatinib and one in Cohort F is related.
One treatment-emergent death occurred during treatment with ponatinib in Cohort F and is not related.
One treatment-emergent death occurred during treatment with ponatinib in Unassigned AP/CP-CML and is related.
One treatment-emergent death occurred during treatment with ponatinib in Cohort E and is related.
Two treatment-emergent deaths (1-Cohort E, 1-Cohort F) occurred during treatment with ponatinib and are not related.
Two treatment-emergent deaths occurred during treatment with ponatinib in Cohort A and one is related.
Three treatment-emergent deaths (1-Cohort D, 1-Cohort E, 1-Cohort F) occurred during treatment with ponatinib and are not related.
One treatment-emergent death occurred during treatment with ponatinib in Cohort D and is related.
Three treatment-emergent deaths (1-Cohort C, 2-Cohort F) occurred during treatment with ponatinib and are not related.
One treatment-emergent death occurred during treatment with ponatinib in Cohort A and is not related.
Twenty-four treatment-emergent deaths (4-Cohort A, 1-Cohort B, 2-Cohort C, 2-Cohort D, 10-Cohort E, 5 Cohort F) occurred during treatment with ponatinib and are not related.
Three treatment-emergent deaths (1-Cohort C, 1-Cohort E, 1-Cohort F) occurred during treatment with ponatinib and are not related.
One treatment-emergent death occurred during treatment with ponatinib in Cohort D and is not related.
One treatment-emergent death occurred during treatment with ponatinib in Cohort B and is not related.
One treatment-emergent death occurred during treatment with ponatinib in Cohort C and is not related.
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Cohort A: CP-CML R-I
|
Cohort B: CP-CML With T315I Mutation
|
Cohort C: AP-CML R-I
|
Cohort D: AP-CML With T315I Mutation
|
Cohort E: BP-CML/Ph+ ALL R-I
|
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
|
Unassigned AP/CP-CML
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
203/203 (100.00%) |
64/64 (100.00%) |
65/65 (100.00%) |
18/18 (100.00%) |
48/48 (100.00%) |
46/46 (100.00%) |
5/5 (100.00%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
Anaemia |
39/203 (19.21%) |
7/64 (10.94%) |
20/65 (30.77%) |
7/18 (38.89%) |
14/48 (29.17%) |
11/46 (23.91%) |
1/5 (20.00%) |
Febrile neutropenia |
1/203 (0.49%) |
1/64 (1.56%) |
2/65 (3.08%) |
0/18 (0.00%) |
3/48 (6.25%) |
3/46 (6.52%) |
0/5 (0.00%) |
Hypochromasia |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Leukopenia |
7/203 (3.45%) |
0/64 (0.00%) |
5/65 (7.69%) |
2/18 (11.11%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Lymphadenopathy |
6/203 (2.96%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
1/5 (20.00%) |
Neutropenia |
42/203 (20.69%) |
6/64 (9.38%) |
24/65 (36.92%) |
4/18 (22.22%) |
13/48 (27.08%) |
7/46 (15.22%) |
0/5 (0.00%) |
Thrombocytopenia |
90/203 (44.33%) |
18/64 (28.13%) |
32/65 (49.23%) |
4/18 (22.22%) |
16/48 (33.33%) |
7/46 (15.22%) |
1/5 (20.00%) |
Cardiac disorders |
|
|
|
|
|
|
|
Angina pectoris |
9/203 (4.43%) |
4/64 (6.25%) |
3/65 (4.62%) |
0/18 (0.00%) |
3/48 (6.25%) |
0/46 (0.00%) |
0/5 (0.00%) |
Atrial fibrillation |
10/203 (4.93%) |
3/64 (4.69%) |
1/65 (1.54%) |
0/18 (0.00%) |
2/48 (4.17%) |
4/46 (8.70%) |
1/5 (20.00%) |
Cardiac failure |
1/203 (0.49%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Cardiomyopathy |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
3/48 (6.25%) |
0/46 (0.00%) |
0/5 (0.00%) |
Palpitations |
6/203 (2.96%) |
1/64 (1.56%) |
2/65 (3.08%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pericardial effusion |
5/203 (2.46%) |
1/64 (1.56%) |
2/65 (3.08%) |
0/18 (0.00%) |
3/48 (6.25%) |
2/46 (4.35%) |
0/5 (0.00%) |
Tachycardia |
3/203 (1.48%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
2/48 (4.17%) |
4/46 (8.70%) |
0/5 (0.00%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
Tinnitus |
8/203 (3.94%) |
1/64 (1.56%) |
1/65 (1.54%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
1/5 (20.00%) |
Vertigo |
8/203 (3.94%) |
1/64 (1.56%) |
3/65 (4.62%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Endocrine disorders |
|
|
|
|
|
|
|
Adrenal insufficiency |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Hypothyroidism |
7/203 (3.45%) |
2/64 (3.13%) |
4/65 (6.15%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Eye disorders |
|
|
|
|
|
|
|
Blepharitis |
3/203 (1.48%) |
1/64 (1.56%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Cataract |
7/203 (3.45%) |
1/64 (1.56%) |
1/65 (1.54%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Conjunctival hyperaemia |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Dry eye |
16/203 (7.88%) |
5/64 (7.81%) |
4/65 (6.15%) |
2/18 (11.11%) |
4/48 (8.33%) |
3/46 (6.52%) |
1/5 (20.00%) |
Eye pain |
8/203 (3.94%) |
4/64 (6.25%) |
2/65 (3.08%) |
0/18 (0.00%) |
3/48 (6.25%) |
0/46 (0.00%) |
0/5 (0.00%) |
Eyelid disorder |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Eyelid oedema |
3/203 (1.48%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Vision blurred |
13/203 (6.40%) |
6/64 (9.38%) |
3/65 (4.62%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Visual acuity reduced |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Visual impairment |
3/203 (1.48%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
1/5 (20.00%) |
Vitreous floaters |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
Abdominal discomfort |
8/203 (3.94%) |
3/64 (4.69%) |
3/65 (4.62%) |
0/18 (0.00%) |
1/48 (2.08%) |
1/46 (2.17%) |
1/5 (20.00%) |
Abdominal distension |
12/203 (5.91%) |
7/64 (10.94%) |
4/65 (6.15%) |
1/18 (5.56%) |
3/48 (6.25%) |
1/46 (2.17%) |
1/5 (20.00%) |
Abdominal pain |
75/203 (36.95%) |
21/64 (32.81%) |
20/65 (30.77%) |
7/18 (38.89%) |
7/48 (14.58%) |
10/46 (21.74%) |
2/5 (40.00%) |
Abdominal pain upper |
40/203 (19.70%) |
10/64 (15.63%) |
11/65 (16.92%) |
2/18 (11.11%) |
6/48 (12.50%) |
8/46 (17.39%) |
2/5 (40.00%) |
Ascites |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Constipation |
89/203 (43.84%) |
21/64 (32.81%) |
16/65 (24.62%) |
7/18 (38.89%) |
21/48 (43.75%) |
13/46 (28.26%) |
3/5 (60.00%) |
Dental necrosis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Diarrhoea |
43/203 (21.18%) |
10/64 (15.63%) |
17/65 (26.15%) |
7/18 (38.89%) |
15/48 (31.25%) |
4/46 (8.70%) |
0/5 (0.00%) |
Dry mouth |
20/203 (9.85%) |
6/64 (9.38%) |
4/65 (6.15%) |
0/18 (0.00%) |
4/48 (8.33%) |
1/46 (2.17%) |
0/5 (0.00%) |
Dyspepsia |
12/203 (5.91%) |
6/64 (9.38%) |
4/65 (6.15%) |
0/18 (0.00%) |
2/48 (4.17%) |
2/46 (4.35%) |
0/5 (0.00%) |
Dysphagia |
3/203 (1.48%) |
1/64 (1.56%) |
2/65 (3.08%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
1/5 (20.00%) |
Gastrooesophageal reflux disease |
10/203 (4.93%) |
8/64 (12.50%) |
2/65 (3.08%) |
0/18 (0.00%) |
2/48 (4.17%) |
0/46 (0.00%) |
1/5 (20.00%) |
Gingival bleeding |
3/203 (1.48%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
2/48 (4.17%) |
2/46 (4.35%) |
1/5 (20.00%) |
Haemorrhoids |
4/203 (1.97%) |
1/64 (1.56%) |
1/65 (1.54%) |
1/18 (5.56%) |
2/48 (4.17%) |
2/46 (4.35%) |
0/5 (0.00%) |
Mouth haemorrhage |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
2/46 (4.35%) |
0/5 (0.00%) |
Nausea |
53/203 (26.11%) |
24/64 (37.50%) |
22/65 (33.85%) |
5/18 (27.78%) |
16/48 (33.33%) |
12/46 (26.09%) |
1/5 (20.00%) |
Odynophagia |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
2/18 (11.11%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Rectal haemorrhage |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
1/5 (20.00%) |
Stomatitis |
11/203 (5.42%) |
2/64 (3.13%) |
4/65 (6.15%) |
1/18 (5.56%) |
2/48 (4.17%) |
3/46 (6.52%) |
0/5 (0.00%) |
Toothache |
13/203 (6.40%) |
0/64 (0.00%) |
3/65 (4.62%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Vomiting |
38/203 (18.72%) |
12/64 (18.75%) |
17/65 (26.15%) |
6/18 (33.33%) |
14/48 (29.17%) |
11/46 (23.91%) |
0/5 (0.00%) |
General disorders |
|
|
|
|
|
|
|
Asthenia |
40/203 (19.70%) |
8/64 (12.50%) |
5/65 (7.69%) |
4/18 (22.22%) |
3/48 (6.25%) |
8/46 (17.39%) |
0/5 (0.00%) |
Chest pain |
13/203 (6.40%) |
4/64 (6.25%) |
1/65 (1.54%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
1/5 (20.00%) |
Chills |
16/203 (7.88%) |
4/64 (6.25%) |
6/65 (9.23%) |
4/18 (22.22%) |
7/48 (14.58%) |
2/46 (4.35%) |
1/5 (20.00%) |
Fatigue |
60/203 (29.56%) |
21/64 (32.81%) |
22/65 (33.85%) |
8/18 (44.44%) |
16/48 (33.33%) |
9/46 (19.57%) |
1/5 (20.00%) |
Feeling hot |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
General physical health deterioration |
1/203 (0.49%) |
2/64 (3.13%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Hernia |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Influenza like illness |
10/203 (4.93%) |
3/64 (4.69%) |
4/65 (6.15%) |
0/18 (0.00%) |
1/48 (2.08%) |
1/46 (2.17%) |
0/5 (0.00%) |
Localised oedema |
1/203 (0.49%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Non-cardiac chest pain |
13/203 (6.40%) |
6/64 (9.38%) |
3/65 (4.62%) |
0/18 (0.00%) |
2/48 (4.17%) |
2/46 (4.35%) |
0/5 (0.00%) |
Oedema peripheral |
36/203 (17.73%) |
8/64 (12.50%) |
9/65 (13.85%) |
5/18 (27.78%) |
12/48 (25.00%) |
5/46 (10.87%) |
1/5 (20.00%) |
Pain |
19/203 (9.36%) |
7/64 (10.94%) |
8/65 (12.31%) |
3/18 (16.67%) |
8/48 (16.67%) |
3/46 (6.52%) |
0/5 (0.00%) |
Performance status decreased |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Peripheral swelling |
5/203 (2.46%) |
4/64 (6.25%) |
5/65 (7.69%) |
2/18 (11.11%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Pyrexia |
52/203 (25.62%) |
13/64 (20.31%) |
20/65 (30.77%) |
11/18 (61.11%) |
16/48 (33.33%) |
12/46 (26.09%) |
0/5 (0.00%) |
Hepatobiliary disorders |
|
|
|
|
|
|
|
Cholelithiasis |
3/203 (1.48%) |
1/64 (1.56%) |
2/65 (3.08%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Immune system disorders |
|
|
|
|
|
|
|
Seasonal allergy |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
|
Bacteraemia |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
3/48 (6.25%) |
2/46 (4.35%) |
0/5 (0.00%) |
Breast cellulitis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Bronchitis |
19/203 (9.36%) |
5/64 (7.81%) |
3/65 (4.62%) |
0/18 (0.00%) |
1/48 (2.08%) |
1/46 (2.17%) |
1/5 (20.00%) |
Cellulitis |
6/203 (2.96%) |
1/64 (1.56%) |
4/65 (6.15%) |
1/18 (5.56%) |
4/48 (8.33%) |
2/46 (4.35%) |
0/5 (0.00%) |
Conjunctivitis |
9/203 (4.43%) |
2/64 (3.13%) |
2/65 (3.08%) |
2/18 (11.11%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Cystitis |
5/203 (2.46%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Ear infection |
1/203 (0.49%) |
1/64 (1.56%) |
2/65 (3.08%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Folliculitis |
8/203 (3.94%) |
6/64 (9.38%) |
3/65 (4.62%) |
1/18 (5.56%) |
1/48 (2.08%) |
2/46 (4.35%) |
1/5 (20.00%) |
Fungaemia |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gastroenteritis |
6/203 (2.96%) |
1/64 (1.56%) |
2/65 (3.08%) |
1/18 (5.56%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Infection |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Influenza |
11/203 (5.42%) |
1/64 (1.56%) |
2/65 (3.08%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Lower respiratory tract infection |
4/203 (1.97%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Mastitis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Mastoiditis |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Nail infection |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Nasopharyngitis |
26/203 (12.81%) |
7/64 (10.94%) |
9/65 (13.85%) |
5/18 (27.78%) |
1/48 (2.08%) |
2/46 (4.35%) |
1/5 (20.00%) |
Oral candidiasis |
4/203 (1.97%) |
1/64 (1.56%) |
1/65 (1.54%) |
1/18 (5.56%) |
3/48 (6.25%) |
1/46 (2.17%) |
0/5 (0.00%) |
Otitis externa |
0/203 (0.00%) |
2/64 (3.13%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Otitis media acute |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Periodontitis |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pharyngitis |
2/203 (0.99%) |
1/64 (1.56%) |
0/65 (0.00%) |
2/18 (11.11%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pneumonia |
7/203 (3.45%) |
1/64 (1.56%) |
2/65 (3.08%) |
1/18 (5.56%) |
4/48 (8.33%) |
1/46 (2.17%) |
0/5 (0.00%) |
Respiratory tract infection |
2/203 (0.99%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Sinusitis |
17/203 (8.37%) |
7/64 (10.94%) |
3/65 (4.62%) |
0/18 (0.00%) |
1/48 (2.08%) |
1/46 (2.17%) |
0/5 (0.00%) |
Tonsillitis |
4/203 (1.97%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Tooth abscess |
1/203 (0.49%) |
0/64 (0.00%) |
2/65 (3.08%) |
1/18 (5.56%) |
1/48 (2.08%) |
1/46 (2.17%) |
0/5 (0.00%) |
Tooth infection |
6/203 (2.96%) |
0/64 (0.00%) |
4/65 (6.15%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Upper respiratory tract infection |
16/203 (7.88%) |
18/64 (28.13%) |
9/65 (13.85%) |
2/18 (11.11%) |
6/48 (12.50%) |
2/46 (4.35%) |
1/5 (20.00%) |
Urinary tract infection |
18/203 (8.87%) |
5/64 (7.81%) |
9/65 (13.85%) |
3/18 (16.67%) |
2/48 (4.17%) |
1/46 (2.17%) |
2/5 (40.00%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
Arthropod bite |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Fall |
9/203 (4.43%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
3/48 (6.25%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hand fracture |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Head injury |
1/203 (0.49%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Laceration |
3/203 (1.48%) |
1/64 (1.56%) |
1/65 (1.54%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Ligament sprain |
4/203 (1.97%) |
1/64 (1.56%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Procedural pain |
5/203 (2.46%) |
2/64 (3.13%) |
2/65 (3.08%) |
2/18 (11.11%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Skin injury |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Subcutaneous haematoma |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Tendon rupture |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Transfusion reaction |
1/203 (0.49%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
2/48 (4.17%) |
1/46 (2.17%) |
0/5 (0.00%) |
Transfusion related complication |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Investigations |
|
|
|
|
|
|
|
Alanine aminotransferase increased |
39/203 (19.21%) |
12/64 (18.75%) |
15/65 (23.08%) |
4/18 (22.22%) |
7/48 (14.58%) |
5/46 (10.87%) |
0/5 (0.00%) |
Amylase increased |
19/203 (9.36%) |
2/64 (3.13%) |
6/65 (9.23%) |
1/18 (5.56%) |
4/48 (8.33%) |
1/46 (2.17%) |
0/5 (0.00%) |
Aspartate aminotransferase increased |
31/203 (15.27%) |
11/64 (17.19%) |
11/65 (16.92%) |
5/18 (27.78%) |
7/48 (14.58%) |
6/46 (13.04%) |
0/5 (0.00%) |
Blood alkaline phosphatase increased |
20/203 (9.85%) |
5/64 (7.81%) |
9/65 (13.85%) |
0/18 (0.00%) |
3/48 (6.25%) |
0/46 (0.00%) |
0/5 (0.00%) |
Blood bilirubin increased |
2/203 (0.99%) |
1/64 (1.56%) |
4/65 (6.15%) |
1/18 (5.56%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Blood cholesterol increased |
9/203 (4.43%) |
3/64 (4.69%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Blood creatinine increased |
8/203 (3.94%) |
4/64 (6.25%) |
5/65 (7.69%) |
0/18 (0.00%) |
5/48 (10.42%) |
1/46 (2.17%) |
0/5 (0.00%) |
Blood glucose increased |
1/203 (0.49%) |
2/64 (3.13%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Blood phosphorus decreased |
1/203 (0.49%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Blood triglycerides increased |
6/203 (2.96%) |
2/64 (3.13%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gamma-glutamyltransferase increased |
16/203 (7.88%) |
5/64 (7.81%) |
5/65 (7.69%) |
3/18 (16.67%) |
2/48 (4.17%) |
0/46 (0.00%) |
0/5 (0.00%) |
Haemoglobin decreased |
2/203 (0.99%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Lipase increased |
56/203 (27.59%) |
15/64 (23.44%) |
10/65 (15.38%) |
2/18 (11.11%) |
8/48 (16.67%) |
3/46 (6.52%) |
0/5 (0.00%) |
N-terminal prohormone brain natriuretic peptide increased |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Neutrophil count decreased |
8/203 (3.94%) |
2/64 (3.13%) |
0/65 (0.00%) |
3/18 (16.67%) |
5/48 (10.42%) |
2/46 (4.35%) |
0/5 (0.00%) |
Platelet count decreased |
15/203 (7.39%) |
3/64 (4.69%) |
6/65 (9.23%) |
1/18 (5.56%) |
2/48 (4.17%) |
3/46 (6.52%) |
0/5 (0.00%) |
Platelet count increased |
3/203 (1.48%) |
1/64 (1.56%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Weight decreased |
23/203 (11.33%) |
5/64 (7.81%) |
7/65 (10.77%) |
0/18 (0.00%) |
5/48 (10.42%) |
2/46 (4.35%) |
1/5 (20.00%) |
White blood cell count decreased |
4/203 (1.97%) |
1/64 (1.56%) |
2/65 (3.08%) |
1/18 (5.56%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
Decreased appetite |
28/203 (13.79%) |
7/64 (10.94%) |
10/65 (15.38%) |
2/18 (11.11%) |
7/48 (14.58%) |
8/46 (17.39%) |
0/5 (0.00%) |
Dehydration |
6/203 (2.96%) |
4/64 (6.25%) |
1/65 (1.54%) |
1/18 (5.56%) |
3/48 (6.25%) |
0/46 (0.00%) |
0/5 (0.00%) |
Gout |
3/203 (1.48%) |
5/64 (7.81%) |
1/65 (1.54%) |
1/18 (5.56%) |
3/48 (6.25%) |
0/46 (0.00%) |
1/5 (20.00%) |
Hyperamylasaemia |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hypercholesterolaemia |
6/203 (2.96%) |
4/64 (6.25%) |
2/65 (3.08%) |
0/18 (0.00%) |
2/48 (4.17%) |
0/46 (0.00%) |
0/5 (0.00%) |
Hyperglycaemia |
8/203 (3.94%) |
7/64 (10.94%) |
9/65 (13.85%) |
0/18 (0.00%) |
3/48 (6.25%) |
2/46 (4.35%) |
0/5 (0.00%) |
Hyperkalaemia |
6/203 (2.96%) |
3/64 (4.69%) |
1/65 (1.54%) |
2/18 (11.11%) |
5/48 (10.42%) |
3/46 (6.52%) |
0/5 (0.00%) |
Hyperuricaemia |
16/203 (7.88%) |
3/64 (4.69%) |
3/65 (4.62%) |
2/18 (11.11%) |
5/48 (10.42%) |
1/46 (2.17%) |
1/5 (20.00%) |
Hypocalcaemia |
7/203 (3.45%) |
1/64 (1.56%) |
8/65 (12.31%) |
1/18 (5.56%) |
5/48 (10.42%) |
4/46 (8.70%) |
0/5 (0.00%) |
Hypokalaemia |
12/203 (5.91%) |
4/64 (6.25%) |
3/65 (4.62%) |
2/18 (11.11%) |
11/48 (22.92%) |
4/46 (8.70%) |
1/5 (20.00%) |
Hypomagnesaemia |
2/203 (0.99%) |
2/64 (3.13%) |
3/65 (4.62%) |
0/18 (0.00%) |
3/48 (6.25%) |
1/46 (2.17%) |
0/5 (0.00%) |
Hyponatraemia |
10/203 (4.93%) |
2/64 (3.13%) |
3/65 (4.62%) |
2/18 (11.11%) |
2/48 (4.17%) |
1/46 (2.17%) |
0/5 (0.00%) |
Hypophosphataemia |
10/203 (4.93%) |
3/64 (4.69%) |
3/65 (4.62%) |
1/18 (5.56%) |
5/48 (10.42%) |
1/46 (2.17%) |
0/5 (0.00%) |
Iron overload |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
3/48 (6.25%) |
0/46 (0.00%) |
0/5 (0.00%) |
Type 2 diabetes mellitus |
1/203 (0.49%) |
2/64 (3.13%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
1/5 (20.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
Arthralgia |
72/203 (35.47%) |
18/64 (28.13%) |
22/65 (33.85%) |
6/18 (33.33%) |
10/48 (20.83%) |
6/46 (13.04%) |
1/5 (20.00%) |
Back pain |
50/203 (24.63%) |
8/64 (12.50%) |
10/65 (15.38%) |
3/18 (16.67%) |
8/48 (16.67%) |
7/46 (15.22%) |
1/5 (20.00%) |
Bone pain |
32/203 (15.76%) |
6/64 (9.38%) |
8/65 (12.31%) |
3/18 (16.67%) |
8/48 (16.67%) |
1/46 (2.17%) |
0/5 (0.00%) |
Flank pain |
2/203 (0.99%) |
0/64 (0.00%) |
3/65 (4.62%) |
1/18 (5.56%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Limb discomfort |
1/203 (0.49%) |
2/64 (3.13%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Muscle spasms |
32/203 (15.76%) |
6/64 (9.38%) |
4/65 (6.15%) |
1/18 (5.56%) |
3/48 (6.25%) |
4/46 (8.70%) |
2/5 (40.00%) |
Muscular weakness |
4/203 (1.97%) |
1/64 (1.56%) |
2/65 (3.08%) |
0/18 (0.00%) |
3/48 (6.25%) |
0/46 (0.00%) |
0/5 (0.00%) |
Musculoskeletal pain |
22/203 (10.84%) |
5/64 (7.81%) |
4/65 (6.15%) |
2/18 (11.11%) |
3/48 (6.25%) |
3/46 (6.52%) |
2/5 (40.00%) |
Myalgia |
47/203 (23.15%) |
18/64 (28.13%) |
14/65 (21.54%) |
4/18 (22.22%) |
10/48 (20.83%) |
3/46 (6.52%) |
0/5 (0.00%) |
Neck pain |
13/203 (6.40%) |
1/64 (1.56%) |
3/65 (4.62%) |
0/18 (0.00%) |
2/48 (4.17%) |
2/46 (4.35%) |
0/5 (0.00%) |
Osteoarthritis |
6/203 (2.96%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
1/5 (20.00%) |
Pain in extremity |
56/203 (27.59%) |
9/64 (14.06%) |
11/65 (16.92%) |
5/18 (27.78%) |
6/48 (12.50%) |
6/46 (13.04%) |
1/5 (20.00%) |
Limb mass |
3/203 (1.48%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
|
Aphasia |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Ataxia |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Burning sensation |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Depressed level of consciousness |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Dizziness |
34/203 (16.75%) |
12/64 (18.75%) |
7/65 (10.77%) |
2/18 (11.11%) |
4/48 (8.33%) |
0/46 (0.00%) |
0/5 (0.00%) |
Dysgeusia |
3/203 (1.48%) |
6/64 (9.38%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Facial paralysis |
3/203 (1.48%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Headache |
87/203 (42.86%) |
27/64 (42.19%) |
18/65 (27.69%) |
7/18 (38.89%) |
15/48 (31.25%) |
12/46 (26.09%) |
1/5 (20.00%) |
Hypoaesthesia |
11/203 (5.42%) |
2/64 (3.13%) |
1/65 (1.54%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Migraine |
6/203 (2.96%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Neuropathy peripheral |
15/203 (7.39%) |
1/64 (1.56%) |
2/65 (3.08%) |
0/18 (0.00%) |
1/48 (2.08%) |
1/46 (2.17%) |
0/5 (0.00%) |
Paraesthesia |
15/203 (7.39%) |
5/64 (7.81%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Radiculopathy |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Sciatica |
11/203 (5.42%) |
0/64 (0.00%) |
4/65 (6.15%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
1/5 (20.00%) |
Somnolence |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
1/48 (2.08%) |
1/46 (2.17%) |
1/5 (20.00%) |
Vith nerve disorder |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Psychiatric disorders |
|
|
|
|
|
|
|
Anxiety |
10/203 (4.93%) |
3/64 (4.69%) |
11/65 (16.92%) |
4/18 (22.22%) |
4/48 (8.33%) |
3/46 (6.52%) |
0/5 (0.00%) |
Confusional state |
4/203 (1.97%) |
1/64 (1.56%) |
1/65 (1.54%) |
2/18 (11.11%) |
2/48 (4.17%) |
3/46 (6.52%) |
0/5 (0.00%) |
Depression |
13/203 (6.40%) |
2/64 (3.13%) |
5/65 (7.69%) |
0/18 (0.00%) |
3/48 (6.25%) |
1/46 (2.17%) |
1/5 (20.00%) |
Hallucination |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Hallucination, visual |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Insomnia |
25/203 (12.32%) |
5/64 (7.81%) |
10/65 (15.38%) |
1/18 (5.56%) |
10/48 (20.83%) |
1/46 (2.17%) |
0/5 (0.00%) |
Libido decreased |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
Acute kidney injury |
3/203 (1.48%) |
1/64 (1.56%) |
1/65 (1.54%) |
0/18 (0.00%) |
3/48 (6.25%) |
0/46 (0.00%) |
0/5 (0.00%) |
Chronic kidney disease |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Dysuria |
6/203 (2.96%) |
2/64 (3.13%) |
3/65 (4.62%) |
2/18 (11.11%) |
3/48 (6.25%) |
1/46 (2.17%) |
0/5 (0.00%) |
Haematuria |
2/203 (0.99%) |
0/64 (0.00%) |
2/65 (3.08%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Hypertonic bladder |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pollakiuria |
7/203 (3.45%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
3/48 (6.25%) |
0/46 (0.00%) |
1/5 (20.00%) |
Renal colic |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Urinary incontinence |
4/203 (1.97%) |
1/64 (1.56%) |
2/65 (3.08%) |
1/18 (5.56%) |
1/48 (2.08%) |
1/46 (2.17%) |
1/5 (20.00%) |
Urinary retention |
4/203 (1.97%) |
1/64 (1.56%) |
3/65 (4.62%) |
1/18 (5.56%) |
0/48 (0.00%) |
2/46 (4.35%) |
0/5 (0.00%) |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
Breast mass |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Erectile dysfunction |
9/203 (4.43%) |
6/64 (9.38%) |
4/65 (6.15%) |
4/18 (22.22%) |
1/48 (2.08%) |
0/46 (0.00%) |
1/5 (20.00%) |
Testicular pain |
0/203 (0.00%) |
1/64 (1.56%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
Asthma |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Catarrh |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Cough |
36/203 (17.73%) |
11/64 (17.19%) |
15/65 (23.08%) |
3/18 (16.67%) |
8/48 (16.67%) |
6/46 (13.04%) |
1/5 (20.00%) |
Dysphonia |
14/203 (6.90%) |
5/64 (7.81%) |
1/65 (1.54%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Dyspnoea |
30/203 (14.78%) |
14/64 (21.88%) |
12/65 (18.46%) |
4/18 (22.22%) |
11/48 (22.92%) |
3/46 (6.52%) |
1/5 (20.00%) |
Epistaxis |
16/203 (7.88%) |
3/64 (4.69%) |
6/65 (9.23%) |
1/18 (5.56%) |
5/48 (10.42%) |
3/46 (6.52%) |
0/5 (0.00%) |
Nasal congestion |
2/203 (0.99%) |
1/64 (1.56%) |
2/65 (3.08%) |
1/18 (5.56%) |
4/48 (8.33%) |
2/46 (4.35%) |
0/5 (0.00%) |
Oropharyngeal pain |
12/203 (5.91%) |
6/64 (9.38%) |
4/65 (6.15%) |
3/18 (16.67%) |
8/48 (16.67%) |
1/46 (2.17%) |
0/5 (0.00%) |
Pharyngeal erythema |
2/203 (0.99%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pleural effusion |
10/203 (4.93%) |
2/64 (3.13%) |
7/65 (10.77%) |
2/18 (11.11%) |
8/48 (16.67%) |
4/46 (8.70%) |
1/5 (20.00%) |
Productive cough |
6/203 (2.96%) |
2/64 (3.13%) |
2/65 (3.08%) |
1/18 (5.56%) |
0/48 (0.00%) |
1/46 (2.17%) |
0/5 (0.00%) |
Sleep apnoea syndrome |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
Alopecia |
19/203 (9.36%) |
4/64 (6.25%) |
5/65 (7.69%) |
4/18 (22.22%) |
4/48 (8.33%) |
3/46 (6.52%) |
0/5 (0.00%) |
Dry skin |
84/203 (41.38%) |
28/64 (43.75%) |
21/65 (32.31%) |
4/18 (22.22%) |
15/48 (31.25%) |
9/46 (19.57%) |
4/5 (80.00%) |
Ecchymosis |
2/203 (0.99%) |
1/64 (1.56%) |
4/65 (6.15%) |
0/18 (0.00%) |
1/48 (2.08%) |
1/46 (2.17%) |
1/5 (20.00%) |
Erythema |
22/203 (10.84%) |
6/64 (9.38%) |
6/65 (9.23%) |
1/18 (5.56%) |
3/48 (6.25%) |
4/46 (8.70%) |
0/5 (0.00%) |
Exfoliative rash |
7/203 (3.45%) |
2/64 (3.13%) |
4/65 (6.15%) |
0/18 (0.00%) |
0/48 (0.00%) |
1/46 (2.17%) |
2/5 (40.00%) |
Generalised erythema |
1/203 (0.49%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Hyperhidrosis |
17/203 (8.37%) |
7/64 (10.94%) |
4/65 (6.15%) |
1/18 (5.56%) |
1/48 (2.08%) |
3/46 (6.52%) |
1/5 (20.00%) |
Hyperkeratosis |
4/203 (1.97%) |
0/64 (0.00%) |
3/65 (4.62%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Night sweats |
15/203 (7.39%) |
10/64 (15.63%) |
4/65 (6.15%) |
1/18 (5.56%) |
2/48 (4.17%) |
2/46 (4.35%) |
0/5 (0.00%) |
Photosensitivity reaction |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Pruritus |
29/203 (14.29%) |
6/64 (9.38%) |
6/65 (9.23%) |
1/18 (5.56%) |
2/48 (4.17%) |
1/46 (2.17%) |
0/5 (0.00%) |
Rash |
28/203 (13.79%) |
3/64 (4.69%) |
10/65 (15.38%) |
3/18 (16.67%) |
2/48 (4.17%) |
3/46 (6.52%) |
0/5 (0.00%) |
Rash erythematous |
39/203 (19.21%) |
21/64 (32.81%) |
9/65 (13.85%) |
2/18 (11.11%) |
11/48 (22.92%) |
8/46 (17.39%) |
0/5 (0.00%) |
Rash generalised |
0/203 (0.00%) |
1/64 (1.56%) |
1/65 (1.54%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Rash macular |
9/203 (4.43%) |
4/64 (6.25%) |
0/65 (0.00%) |
1/18 (5.56%) |
2/48 (4.17%) |
0/46 (0.00%) |
0/5 (0.00%) |
Rash maculo-papular |
21/203 (10.34%) |
11/64 (17.19%) |
4/65 (6.15%) |
1/18 (5.56%) |
3/48 (6.25%) |
0/46 (0.00%) |
0/5 (0.00%) |
Rash papular |
14/203 (6.90%) |
4/64 (6.25%) |
5/65 (7.69%) |
1/18 (5.56%) |
3/48 (6.25%) |
1/46 (2.17%) |
2/5 (40.00%) |
Rash pruritic |
21/203 (10.34%) |
6/64 (9.38%) |
5/65 (7.69%) |
3/18 (16.67%) |
2/48 (4.17%) |
1/46 (2.17%) |
1/5 (20.00%) |
Skin disorder |
1/203 (0.49%) |
1/64 (1.56%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Skin exfoliation |
12/203 (5.91%) |
6/64 (9.38%) |
2/65 (3.08%) |
1/18 (5.56%) |
0/48 (0.00%) |
2/46 (4.35%) |
1/5 (20.00%) |
Skin lesion |
4/203 (1.97%) |
1/64 (1.56%) |
3/65 (4.62%) |
1/18 (5.56%) |
0/48 (0.00%) |
2/46 (4.35%) |
0/5 (0.00%) |
Urticaria |
0/203 (0.00%) |
0/64 (0.00%) |
1/65 (1.54%) |
1/18 (5.56%) |
2/48 (4.17%) |
2/46 (4.35%) |
0/5 (0.00%) |
Social circumstances |
|
|
|
|
|
|
|
Activities of daily living impaired |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Vascular disorders |
|
|
|
|
|
|
|
Flushing |
8/203 (3.94%) |
2/64 (3.13%) |
4/65 (6.15%) |
0/18 (0.00%) |
1/48 (2.08%) |
0/46 (0.00%) |
0/5 (0.00%) |
Haemorrhage |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Hot flush |
12/203 (5.91%) |
1/64 (1.56%) |
4/65 (6.15%) |
0/18 (0.00%) |
0/48 (0.00%) |
0/46 (0.00%) |
1/5 (20.00%) |
Hypertension |
68/203 (33.50%) |
21/64 (32.81%) |
13/65 (20.00%) |
8/18 (44.44%) |
13/48 (27.08%) |
8/46 (17.39%) |
2/5 (40.00%) |
Hypotension |
6/203 (2.96%) |
0/64 (0.00%) |
1/65 (1.54%) |
0/18 (0.00%) |
3/48 (6.25%) |
1/46 (2.17%) |
0/5 (0.00%) |
Peripheral ischaemia |
0/203 (0.00%) |
2/64 (3.13%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Peripheral venous disease |
0/203 (0.00%) |
0/64 (0.00%) |
0/65 (0.00%) |
1/18 (5.56%) |
0/48 (0.00%) |
0/46 (0.00%) |
0/5 (0.00%) |
Term from vocabulary, MedDRA version 19.0
Indicates events were collected by systematic assessment
|