Trial Outcomes & Findings for Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2) (NCT NCT00234065)
NCT ID: NCT00234065
Last Updated: 2011-06-10
Results Overview
The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2800 participants
Primary outcome timeframe
From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])
Results posted on
2011-06-10
Participant Flow
Patients with non-cardioembolic ischemic stroke have been recruited at 278 study sites in Japan between December, 2003, and October, 2006.
No screening period
Participant milestones
| Measure |
Cilostazol
cilostazol, oral tablet, 100 mg cilostazol
|
Aspirin
Aspirin, oral tablet, 81 mg aspirin
|
|---|---|---|
|
Overall Study
STARTED
|
1356
|
1360
|
|
Overall Study
COMPLETED
|
881
|
1004
|
|
Overall Study
NOT COMPLETED
|
475
|
356
|
Reasons for withdrawal
| Measure |
Cilostazol
cilostazol, oral tablet, 100 mg cilostazol
|
Aspirin
Aspirin, oral tablet, 81 mg aspirin
|
|---|---|---|
|
Overall Study
Adverse Event
|
268
|
166
|
|
Overall Study
Withdrawal by Subject
|
73
|
56
|
|
Overall Study
Physician Decision
|
23
|
22
|
|
Overall Study
Not Classified
|
111
|
112
|
Baseline Characteristics
Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
Baseline characteristics by cohort
| Measure |
Cilostazol
n=1337 Participants
cilostazol, oral tablet, 100 mg cilostazol
|
Aspirin
n=1335 Participants
Aspirin, oral tablet, 81 mg aspirin
|
Total
n=2672 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
681 Participants
n=99 Participants
|
685 Participants
n=107 Participants
|
1366 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
656 Participants
n=99 Participants
|
650 Participants
n=107 Participants
|
1306 Participants
n=206 Participants
|
|
Age Continuous
|
63.5 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
63.4 years
STANDARD_DEVIATION 9.0 • n=107 Participants
|
63.4 years
STANDARD_DEVIATION 9.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
378 Participants
n=99 Participants
|
378 Participants
n=107 Participants
|
756 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
959 Participants
n=99 Participants
|
957 Participants
n=107 Participants
|
1916 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
1337 participants
n=99 Participants
|
1335 participants
n=107 Participants
|
2672 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])Population: Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.
The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Outcome measures
| Measure |
Cilostazol
n=1337 Participants
cilostazol, oral tablet, 100 mg cilostazol
|
Aspirin
n=1335 Participants
Aspirin, oral tablet, 81 mg aspirin
|
|---|---|---|
|
Numbers of Patients With First Occurence of Stroke
|
82 participants
|
119 participants
|
SECONDARY outcome
Timeframe: From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])Outcome measures
| Measure |
Cilostazol
n=1337 Participants
cilostazol, oral tablet, 100 mg cilostazol
|
Aspirin
n=1335 Participants
Aspirin, oral tablet, 81 mg aspirin
|
|---|---|---|
|
Number of Patients With First Recurrence of Cerebral Infarction
|
72 participants
|
88 participants
|
SECONDARY outcome
Timeframe: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])Population: Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.
The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction or the first occurrence of transient ischaemic attack. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Outcome measures
| Measure |
Cilostazol
n=1337 Participants
cilostazol, oral tablet, 100 mg cilostazol
|
Aspirin
n=1335 Participants
Aspirin, oral tablet, 81 mg aspirin
|
|---|---|---|
|
Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease
|
86 participants
|
103 participants
|
SECONDARY outcome
Timeframe: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])Number of deaths from any cause. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Outcome measures
| Measure |
Cilostazol
n=1337 Participants
cilostazol, oral tablet, 100 mg cilostazol
|
Aspirin
n=1335 Participants
Aspirin, oral tablet, 81 mg aspirin
|
|---|---|---|
|
Number of Deaths From Any Cause
|
13 participants
|
13 participants
|
SECONDARY outcome
Timeframe: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage, subarachnoid haemorrhage, transient ischaemic attack, angina pectris, myocardial infarction, heart failure, or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Outcome measures
| Measure |
Cilostazol
n=1337 Participants
cilostazol, oral tablet, 100 mg cilostazol
|
Aspirin
n=1335 Participants
Aspirin, oral tablet, 81 mg aspirin
|
|---|---|---|
|
Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events
|
138 participants
|
186 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])The endpoint in this measure is a composite endpoint of the first occurrence of cerebral haemorrhage, subarachnoid haemorrhage or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Outcome measures
| Measure |
Cilostazol
n=1337 Participants
cilostazol, oral tablet, 100 mg cilostazol
|
Aspirin
n=1335 Participants
Aspirin, oral tablet, 81 mg aspirin
|
|---|---|---|
|
Number of Patients With First Occurrence of Haemorrhagic Event
|
23 participants
|
57 participants
|
Adverse Events
Cilostazol
Serious events: 372 serious events
Other events: 1267 other events
Deaths: 0 deaths
Aspirin
Serious events: 433 serious events
Other events: 1260 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cilostazol
n=1337 participants at risk
cilostazol, oral tablet, 100 mg cilostazol
|
Aspirin
n=1335 participants at risk
Aspirin, oral tablet, 81 mg aspirin
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.37%
5/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Myocardial infarction
|
0.75%
10/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Angina pectoris
|
0.52%
7/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.45%
6/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Atrial fibrillation
|
0.45%
6/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Acute myocardial infarction
|
0.30%
4/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.52%
7/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Cardiac failure
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Cardiac failure congestive
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Angina unstable
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Cardiac failure acute
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Myocardial ischaemia
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Prinzmetal angina
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Intracardiac thrombus
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Congenital, familial and genetic disorders
Intestinal malrotation
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Ear and labyrinth disorders
Vertigo
|
0.30%
4/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Ear and labyrinth disorders
Vertigo labyrinthine
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Cataract
|
1.6%
22/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
1.3%
17/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Macular oedema
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Cataract subcapsular
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Diabetic retinal oedema
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Pterygium
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Vitreous haemorrhage
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Entropion
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Ulcerative keratitis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Amaurosis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Cataract diabetic
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Macular degeneration
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Retinal detachment
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Macular hole
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Eye disorders
Tolosa-Hunt syndrome
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.82%
11/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.37%
5/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Colonic polyp
|
0.75%
10/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.52%
7/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.45%
6/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Enterocolitis
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Periodontitis
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Anal fistula
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Gastric polyps
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.67%
9/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Ileus
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Melaena
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Nausea
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Peritonitis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
General disorders
Food poisoning
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
General disorders
Disuse syndrome
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Granuloma
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
General disorders
Sudden death
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
General disorders
Chest pain
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
General disorders
Mass
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
General disorders
Cardiac death
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
General disorders
Gait disturbance
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
General disorders
Pyrexia
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.37%
5/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Hepatobiliary disorders
Bile duct stone
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Hepatobiliary disorders
Cholangitis
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Hepatobiliary disorders
Liver disorder
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Hepatobiliary disorders
Biliary cirrhosis primary
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Pneumonia
|
0.60%
8/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.67%
9/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Gastroenteritis
|
0.37%
5/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Appendicitis
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Bronchitis
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Herpes zoster
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Pyelonephritis
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Pyelonephritis acute
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Sinusitis
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Urinary tract infection
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Enteritis infectious
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Appendicitis perforated
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Bronchopneumonia
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Cellulitis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Diverticulitis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Herpes virus infection
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Influenza
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Nasopharyngitis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Postoperative wound infection
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Retroperitoneal abscess
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Viral infection
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Anal abscess
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Postoperative abscess
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Extradural abscess
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Varicella
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Anogenital warts
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.45%
6/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.45%
6/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Contusion
|
0.45%
6/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Injury
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Muscle strain
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Investigations
Blood urea increased
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Investigations
Blood glucose increased
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Investigations
Blood pressure increased
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Investigations
Blood glucose fluctuation
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Investigations
Blood potassium increased
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Investigations
Platelet count decreased
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.37%
5/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.45%
6/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.37%
5/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Metabolism and nutrition disorders
Back pain
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.67%
9/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.60%
8/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.60%
8/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.30%
4/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the gastrointestinal tract
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Cerebral infarction
|
4.6%
62/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
6.3%
84/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Transient ischaemic attack
|
0.60%
8/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.67%
9/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Dizziness
|
0.52%
7/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.45%
6/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.30%
4/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
1.9%
25/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Epilepsy
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Loss of consciousness
|
0.22%
3/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Facial palsy
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Syncope
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Convulsion
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Headache
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Hypoaesthesia
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Paralysis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Presenile dementia
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Putamen haemorrhage
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Psychiatric disorders
Delirium
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Psychiatric disorders
Anxiety disorder
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Psychiatric disorders
Anxiety
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Psychiatric disorders
Completed suicide
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Psychiatric disorders
Suicide attempt
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Psychiatric disorders
Depression
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Psychiatric disorders
Dissociative disorder
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Psychiatric disorders
Mania
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Calculus bladder
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Calculus ureteric
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Calculus urethral
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Hydronephrosis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Renal failure acute
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Bladder prolapse
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.30%
4/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.15%
2/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic disorder
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.30%
4/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Vascular disorders
Shock haemorrhagic
|
0.15%
2/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Vascular disorders
Aneurysm
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Vascular disorders
Aortic aneurysm
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Vascular disorders
Varicose vein
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.22%
3/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.07%
1/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.00%
0/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
0.07%
1/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
Other adverse events
| Measure |
Cilostazol
n=1337 participants at risk
cilostazol, oral tablet, 100 mg cilostazol
|
Aspirin
n=1335 participants at risk
Aspirin, oral tablet, 81 mg aspirin
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
11.7%
156/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
5.3%
71/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Cardiac disorders
Tachycardia
|
6.7%
89/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
1.6%
21/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Diarrhoea
|
12.3%
164/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
6.4%
85/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Constipation
|
8.2%
110/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
11.6%
155/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Dental caries
|
7.0%
93/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
8.5%
114/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Gastrointestinal disorders
Periodontitis
|
5.8%
77/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
4.8%
64/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Infections and infestations
Nasopharyngitis
|
40.8%
546/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
44.2%
590/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Injury, poisoning and procedural complications
Contusion
|
9.6%
128/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
9.1%
121/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Investigations
Blood glucose increased
|
6.9%
92/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
5.9%
79/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Investigations
Blood pressure increased
|
5.3%
71/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
6.6%
88/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Investigations
Blood creatine phosphokinase increased
|
5.0%
67/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
5.7%
76/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.2%
96/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
5.6%
75/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
160/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
12.4%
165/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
118/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
7.6%
102/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.5%
73/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
4.1%
55/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Headache
|
23.3%
312/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
16.3%
217/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Nervous system disorders
Dizziness
|
9.3%
124/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
6.9%
92/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Psychiatric disorders
Insomnia
|
6.1%
81/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
7.2%
96/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.3%
97/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
7.9%
105/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.3%
97/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
7.8%
104/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
|
Vascular disorders
Hypertension
|
9.0%
120/1337 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
13.9%
185/1335 • From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])
|
Additional Information
Masahiko Abe, Director Cardiovascular Projects
Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
Phone: +81-6-6943-7722
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place