Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)
Sponsor
Otsuka Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT00234065
Collaborator
(none)
2,800
1
2
60
46.6
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Post-marketing Study of Cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison With Aspirin
Study Start Date
:
Dec 1, 2003
Actual Primary Completion Date
:
Dec 1, 2008
Actual Study Completion Date
:
Dec 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 cilostazol |
Drug: Cilostazol
oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years
|
| Active Comparator: 2 Aspirin |
Drug: Aspirin
oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years
|
Outcome Measures
Primary Outcome Measures
- Numbers of Patients With First Occurence of Stroke [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 or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
Secondary Outcome Measures
- Number of Patients With First Recurrence of Cerebral Infarction [From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])]
- Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease [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 the first occurrence of transient ischaemic attack. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.
- Number of Deaths From Any Cause [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.
- Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events [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.
Other Outcome Measures
- Number of Patients With First Occurrence of Haemorrhagic Event [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction
-
Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI
-
Patients aged 20 to 80 years (inclusive) at time of consent
-
Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale
-
Patients without asymptomatic cerebral infarction
-
Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction
-
Patients without severe disturbances/impairments following occurrence of cerebral
Exclusion Criteria:
-
Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
-
Pregnant, possibly pregnant, or nursing women
-
Patients with ischemic heart failure
-
Patients with peptic ulcer
-
Patients with severer blood disorders
-
Patients with severe hepatic or renal
-
Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
-
Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
-
Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
-
Patients who are being treated with ticlopidine hydrochloride
-
Patients who are participating in another study for an investigational drug
-
Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Otsuka Pharmaceutical Co., Ltd. | Tokyo | Japan |
Sponsors and Collaborators
- Otsuka Pharmaceutical Co., Ltd.
Investigators
- Study Director: Masahiko Abe, Division of New Product Evaluation and Development
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00234065
Other Study ID Numbers:
- C02100-002
- JapicCTI-050034
- UMIN-CTR-C000000129
First Posted:
Oct 6, 2005
Last Update Posted:
Jun 10, 2011
Last Verified:
Jun 1, 2011
Study Results
Participant Flow
| Recruitment Details | Patients with non-cardioembolic ischemic stroke have been recruited at 278 study sites in Japan between December, 2003, and October, 2006. |
|---|---|
| Pre-assignment Detail | No screening period |
| Arm/Group Title | Cilostazol | Aspirin |
|---|---|---|
| Arm/Group Description | cilostazol, oral tablet, 100 mg cilostazol | Aspirin, oral tablet, 81 mg aspirin |
| Period Title: Overall Study | ||
| STARTED | 1356 | 1360 |
| COMPLETED | 881 | 1004 |
| NOT COMPLETED | 475 | 356 |
Baseline Characteristics
| Arm/Group Title | Cilostazol | Aspirin | Total |
|---|---|---|---|
| Arm/Group Description | cilostazol, oral tablet, 100 mg cilostazol | Aspirin, oral tablet, 81 mg aspirin | Total of all reporting groups |
| Overall Participants | 1337 | 1335 | 2672 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
681
50.9%
|
685
51.3%
|
1366
51.1%
|
| >=65 years |
656
49.1%
|
650
48.7%
|
1306
48.9%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
63.5
(9.2)
|
63.4
(9.0)
|
63.4
(9.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
378
28.3%
|
378
28.3%
|
756
28.3%
|
| Male |
959
71.7%
|
957
71.7%
|
1916
71.7%
|
| Region of Enrollment (participants) [Number] | |||
| Japan |
1337
100%
|
1335
100%
|
2672
100%
|
Outcome Measures
| Title | Numbers of Patients With First Occurence of Stroke |
|---|---|
| Description | 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. |
| Time Frame | From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Cilostazol | Aspirin |
|---|---|---|
| Arm/Group Description | cilostazol, oral tablet, 100 mg cilostazol | Aspirin, oral tablet, 81 mg aspirin |
| Measure Participants | 1337 | 1335 |
| Number [participants] |
82
6.1%
|
119
8.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cilostazol, Aspirin |
|---|---|---|
| Comments | Statistical Analysis 1 for Number of Patients With First Occurrence of Stroke | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | If the upper 95% CI limit for the HR of cilostazol to aspirin was 1.33 (4/3) or lower , cilostazol would be non-inferior to aspirin. | |
| Statistical Test of Hypothesis | p-Value | 0.0357 |
| Comments | The log-rank test was used to verify the superiority of CLZ to ASA only if non-inferiority was verified. The adjusted significance level for the superiority test of the endpoint was set at 0.0471 (two-tailed) according to the O'Brien-Fleming method. | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio, log |
| Estimated Value | 0.743 | |
| Confidence Interval |
(2-Sided) 95% 0.564 to 0.981 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With First Recurrence of Cerebral Infarction |
|---|---|
| Description | |
| Time Frame | From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cilostazol | Aspirin |
|---|---|---|
| Arm/Group Description | cilostazol, oral tablet, 100 mg cilostazol | Aspirin, oral tablet, 81 mg aspirin |
| Measure Participants | 1337 | 1335 |
| Number [participants] |
72
5.4%
|
88
6.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cilostazol, Aspirin |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4189 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio, log |
| Estimated Value | 0.88 | |
| Confidence Interval |
(2-Sided) 95% 0.645 to 1.200 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease |
|---|---|
| Description | 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. |
| Time Frame | From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Cilostazol | Aspirin |
|---|---|---|
| Arm/Group Description | cilostazol, oral tablet, 100 mg cilostazol | Aspirin, oral tablet, 81 mg aspirin |
| Measure Participants | 1337 | 1335 |
| Number [participants] |
86
6.4%
|
103
7.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cilostazol, Aspirin |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4582 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.898 | |
| Confidence Interval |
(2-Sided) 95% 0.675 to 1.194 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Deaths From Any Cause |
|---|---|
| Description | Number of deaths from any cause. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints. |
| Time Frame | From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cilostazol | Aspirin |
|---|---|---|
| Arm/Group Description | cilostazol, oral tablet, 100 mg cilostazol | Aspirin, oral tablet, 81 mg aspirin |
| Measure Participants | 1337 | 1335 |
| Number [participants] |
13
1%
|
13
1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cilostazol, Aspirin |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8600 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.072 | |
| Confidence Interval |
(2-Sided) 95% 0.497 to 2.313 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events |
|---|---|
| Description | 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. |
| Time Frame | From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cilostazol | Aspirin |
|---|---|---|
| Arm/Group Description | cilostazol, oral tablet, 100 mg cilostazol | Aspirin, oral tablet, 81 mg aspirin |
| Measure Participants | 1337 | 1335 |
| Number [participants] |
138
10.3%
|
186
13.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cilostazol, Aspirin |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0437 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.799 | |
| Confidence Interval |
(2-Sided) 95% 0.643 to 0.994 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Patients With First Occurrence of Haemorrhagic Event |
|---|---|
| Description | 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. |
| Time Frame | From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cilostazol | Aspirin |
|---|---|---|
| Arm/Group Description | cilostazol, oral tablet, 100 mg cilostazol | Aspirin, oral tablet, 81 mg aspirin |
| Measure Participants | 1337 | 1335 |
| Number [participants] |
23
1.7%
|
57
4.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cilostazol, Aspirin |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0004 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.458 | |
| Confidence Interval |
(2-Sided) 95% 0.296 to 0.711 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months]) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Cilostazol | Aspirin | ||
| Arm/Group Description | cilostazol, oral tablet, 100 mg cilostazol | Aspirin, oral tablet, 81 mg aspirin | ||
All Cause Mortality |
||||
| Cilostazol | Aspirin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Cilostazol | Aspirin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 372/1337 (27.8%) | 433/1335 (32.4%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/1337 (0.1%) | 5/1335 (0.4%) | ||
| Thrombocytopenia | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Anaemia macrocytic | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Disseminated intravascular coagulation | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Hypochromic anaemia | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Iron deficiency anaemia | 0/1337 (0%) | 4/1335 (0.3%) | ||
| Lymphadenopathy | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Cardiac disorders | ||||
| Myocardial infarction | 10/1337 (0.7%) | 3/1335 (0.2%) | ||
| Angina pectoris | 7/1337 (0.5%) | 6/1335 (0.4%) | ||
| Atrial fibrillation | 6/1337 (0.4%) | 0/1335 (0%) | ||
| Acute myocardial infarction | 4/1337 (0.3%) | 7/1335 (0.5%) | ||
| Cardiac failure | 3/1337 (0.2%) | 4/1335 (0.3%) | ||
| Cardiac failure congestive | 3/1337 (0.2%) | 1/1335 (0.1%) | ||
| Angina unstable | 2/1337 (0.1%) | 4/1335 (0.3%) | ||
| Cardiac failure acute | 2/1337 (0.1%) | 2/1335 (0.1%) | ||
| Ventricular extrasystoles | 2/1337 (0.1%) | 1/1335 (0.1%) | ||
| Myocardial ischaemia | 1/1337 (0.1%) | 3/1335 (0.2%) | ||
| Prinzmetal angina | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Intracardiac thrombus | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Stress cardiomyopathy | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Aortic valve stenosis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Atrial flutter | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Atrioventricular block complete | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Atrioventricular block second degree | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Coronary artery stenosis | 0/1337 (0%) | 3/1335 (0.2%) | ||
| Silent myocardial infarction | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Congenital, familial and genetic disorders | ||||
| Hydrocele | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Intestinal malrotation | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 4/1337 (0.3%) | 1/1335 (0.1%) | ||
| Vertigo positional | 3/1337 (0.2%) | 2/1335 (0.1%) | ||
| Sudden hearing loss | 3/1337 (0.2%) | 3/1335 (0.2%) | ||
| Meniere's disease | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Vertigo labyrinthine | 1/1337 (0.1%) | 2/1335 (0.1%) | ||
| Eye disorders | ||||
| Cataract | 22/1337 (1.6%) | 17/1335 (1.3%) | ||
| Macular oedema | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Cataract subcapsular | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Diabetic retinal oedema | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Pterygium | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Vitreous haemorrhage | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Entropion | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Ulcerative keratitis | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Amaurosis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Cataract diabetic | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Diabetic retinopathy | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Macular degeneration | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Retinal detachment | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Retinal haemorrhage | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Retinal vein occlusion | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Macular hole | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Tolosa-Hunt syndrome | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Gastrointestinal disorders | ||||
| Inguinal hernia | 11/1337 (0.8%) | 5/1335 (0.4%) | ||
| Colonic polyp | 10/1337 (0.7%) | 7/1335 (0.5%) | ||
| Gastric ulcer | 6/1337 (0.4%) | 4/1335 (0.3%) | ||
| Enterocolitis | 2/1337 (0.1%) | 2/1335 (0.1%) | ||
| Haemorrhoids | 2/1337 (0.1%) | 3/1335 (0.2%) | ||
| Hiatus hernia | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Intestinal obstruction | 2/1337 (0.1%) | 1/1335 (0.1%) | ||
| Periodontitis | 2/1337 (0.1%) | 3/1335 (0.2%) | ||
| Reflux oesophagitis | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Anal fistula | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Colitis ischaemic | 1/1337 (0.1%) | 4/1335 (0.3%) | ||
| Diverticulum intestinal haemorrhagic | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Gastric polyps | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Gastric ulcer haemorrhage | 1/1337 (0.1%) | 9/1335 (0.7%) | ||
| Gastrointestinal disorder | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Gastrointestinal haemorrhage | 1/1337 (0.1%) | 4/1335 (0.3%) | ||
| Ileus | 1/1337 (0.1%) | 2/1335 (0.1%) | ||
| Ileus paralytic | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Mallory-Weiss syndrome | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Melaena | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Nausea | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Pancreatitis acute | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Peritonitis | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Large intestinal haemorrhage | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Diverticulitis intestinal haemorrhagic | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Duodenal ulcer | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Duodenal ulcer haemorrhage | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Gastritis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Gastritis erosive | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Gastroduodenal ulcer | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Gingival hyperplasia | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Large intestinal ulcer | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Upper gastrointestinal haemorrhage | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Lower gastrointestinal haemorrhage | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Varices oesophageal | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Granuloma | 2/1337 (0.1%) | 0/1335 (0%) | ||
| General disorders | ||||
| Food poisoning | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Disuse syndrome | 3/1337 (0.2%) | 1/1335 (0.1%) | ||
| Sudden death | 2/1337 (0.1%) | 2/1335 (0.1%) | ||
| Chest pain | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Mass | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Cardiac death | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Gait disturbance | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Pyrexia | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Hepatobiliary disorders | ||||
| Hepatic function abnormal | 5/1337 (0.4%) | 3/1335 (0.2%) | ||
| Bile duct stone | 3/1337 (0.2%) | 2/1335 (0.1%) | ||
| Cholangitis | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Autoimmune hepatitis | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Cholecystitis acute | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Cholelithiasis | 1/1337 (0.1%) | 3/1335 (0.2%) | ||
| Liver disorder | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Biliary cirrhosis primary | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Cholecystitis | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Hepatic cirrhosis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Jaundice cholestatic | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Infections and infestations | ||||
| Pneumonia | 8/1337 (0.6%) | 9/1335 (0.7%) | ||
| Gastroenteritis | 5/1337 (0.4%) | 3/1335 (0.2%) | ||
| Appendicitis | 3/1337 (0.2%) | 1/1335 (0.1%) | ||
| Bronchitis | 3/1337 (0.2%) | 1/1335 (0.1%) | ||
| Herpes zoster | 3/1337 (0.2%) | 1/1335 (0.1%) | ||
| Pyelonephritis | 3/1337 (0.2%) | 3/1335 (0.2%) | ||
| Pyelonephritis acute | 3/1337 (0.2%) | 3/1335 (0.2%) | ||
| Sinusitis | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Urinary tract infection | 2/1337 (0.1%) | 3/1335 (0.2%) | ||
| Enteritis infectious | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Appendicitis perforated | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Bronchopneumonia | 1/1337 (0.1%) | 2/1335 (0.1%) | ||
| Cellulitis | 1/1337 (0.1%) | 3/1335 (0.2%) | ||
| Diverticulitis | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Herpes virus infection | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Influenza | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Nasopharyngitis | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Postoperative wound infection | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Retroperitoneal abscess | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Viral infection | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Anal abscess | 1/1337 (0.1%) | 2/1335 (0.1%) | ||
| Postoperative abscess | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Extradural abscess | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Osteomyelitis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Pelvic abscess | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Pseudomembranous colitis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Varicella | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Anogenital warts | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Pneumonia bacterial | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Pneumocystis jiroveci pneumonia | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Enterocolitis bacterial | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Muscle strain | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Femoral neck fracture | 6/1337 (0.4%) | 1/1335 (0.1%) | ||
| Spinal compression fracture | 6/1337 (0.4%) | 4/1335 (0.3%) | ||
| Contusion | 6/1337 (0.4%) | 2/1335 (0.1%) | ||
| Subdural haematoma | 3/1337 (0.2%) | 2/1335 (0.1%) | ||
| Facial bones fracture | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Hand fracture | 2/1337 (0.1%) | 1/1335 (0.1%) | ||
| Humerus fracture | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Rib fracture | 2/1337 (0.1%) | 4/1335 (0.3%) | ||
| Ankle fracture | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Carbon monoxide poisoning | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Femur fracture | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Injury | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Multiple fractures | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Spinal cord injury | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Tendon rupture | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Cervical vertebral fracture | 1/1337 (0.1%) | 2/1335 (0.1%) | ||
| Lumbar vertebral fracture | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Thermal burn | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Eye injury | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Pelvic fracture | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Upper limb fracture | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Renal injury | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Lower limb fracture | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Burns third degree | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Clavicle fracture | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Compression fracture | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Extradural haematoma | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Foot fracture | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Forearm fracture | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Head injury | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Joint dislocation | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Joint sprain | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Open fracture | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Radius fracture | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Road traffic accident | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Subcutaneous haematoma | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Tibia fracture | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Brain contusion | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Meniscus lesion | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Skin laceration | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Skull fracture | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Limb traumatic amputation | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Investigations | ||||
| Blood urea increased | 2/1337 (0.1%) | 1/1335 (0.1%) | ||
| Blood glucose increased | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Blood pressure increased | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Blood glucose fluctuation | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Blood creatine phosphokinase increased | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Blood potassium increased | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Platelet count decreased | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus | 5/1337 (0.4%) | 6/1335 (0.4%) | ||
| Hypoglycaemia | 5/1337 (0.4%) | 1/1335 (0.1%) | ||
| Anorexia | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Dehydration | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Diabetes mellitus inadequate control | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Hyperglycaemia | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Hypoalbuminaemia | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Malnutrition | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Type 2 diabetes mellitus | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Back pain | 3/1337 (0.2%) | 3/1335 (0.2%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Osteoarthritis | 2/1337 (0.1%) | 2/1335 (0.1%) | ||
| Arthritis | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Rotator cuff syndrome | 1/1337 (0.1%) | 2/1335 (0.1%) | ||
| Temporomandibular joint syndrome | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Intervertebral disc protrusion | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Spinal ligament ossification | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Arthralgia | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Lumbar spinal stenosis | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Muscle haemorrhage | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Pain in extremity | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Periostitis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Rhabdomyolysis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Spinal osteoarthritis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Tenosynovitis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Axillary mass | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Spondylolisthesis | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Gastric cancer | 9/1337 (0.7%) | 8/1335 (0.6%) | ||
| Large intestine carcinoma | 8/1337 (0.6%) | 4/1335 (0.3%) | ||
| Lung neoplasm malignant | 4/1337 (0.3%) | 4/1335 (0.3%) | ||
| Brain neoplasm | 3/1337 (0.2%) | 1/1335 (0.1%) | ||
| Bladder cancer | 2/1337 (0.1%) | 2/1335 (0.1%) | ||
| Colon cancer | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Pancreatic carcinoma | 2/1337 (0.1%) | 2/1335 (0.1%) | ||
| Colon adenoma | 2/1337 (0.1%) | 1/1335 (0.1%) | ||
| Thyroid cancer | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Bladder papilloma | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Carcinoid tumour of the gastrointestinal tract | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Hepatic neoplasm malignant | 1/1337 (0.1%) | 2/1335 (0.1%) | ||
| Laryngeal cancer | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Lung adenocarcinoma | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Lymphoma | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Malignant ascites | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Malignant neoplasm of renal pelvis | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Metastases to liver | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Neoplasm skin | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Oesophageal carcinoma | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Rectal cancer | 1/1337 (0.1%) | 2/1335 (0.1%) | ||
| Renal cancer | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Thyroid neoplasm | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Small intestine carcinoma | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Gastric adenoma | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Prostate cancer | 1/1337 (0.1%) | 4/1335 (0.3%) | ||
| Metastatic neoplasm | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Salivary gland neoplasm | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Spinal cord neoplasm | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Renal cell carcinoma | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Adenoma benign | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Bowen's disease | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Breast cancer | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Cervix carcinoma | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Haemangioma of liver | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Kaposi's sarcoma | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Lipoma | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Liposarcoma | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Metastases to lymph nodes | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Neoplasm | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Small cell lung cancer stage unspecified | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Thyroid adenoma | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Ureteric cancer | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Uterine cancer | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Salivary gland adenoma | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Pancreatic carcinoma stage IV | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Adrenal neoplasm | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Metastatic gastric cancer | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Nervous system disorders | ||||
| Cerebral infarction | 62/1337 (4.6%) | 84/1335 (6.3%) | ||
| Transient ischaemic attack | 8/1337 (0.6%) | 9/1335 (0.7%) | ||
| Dizziness | 7/1337 (0.5%) | 6/1335 (0.4%) | ||
| Cerebral haemorrhage | 4/1337 (0.3%) | 25/1335 (1.9%) | ||
| Epilepsy | 3/1337 (0.2%) | 3/1335 (0.2%) | ||
| Loss of consciousness | 3/1337 (0.2%) | 1/1335 (0.1%) | ||
| Facial palsy | 2/1337 (0.1%) | 1/1335 (0.1%) | ||
| Subarachnoid haemorrhage | 2/1337 (0.1%) | 4/1335 (0.3%) | ||
| Syncope | 2/1337 (0.1%) | 2/1335 (0.1%) | ||
| Convulsion | 1/1337 (0.1%) | 3/1335 (0.2%) | ||
| Dementia Alzheimer's type | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Haemorrhagic cerebral infarction | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Headache | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Hypoaesthesia | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Hypoglycaemic coma | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Intraventricular haemorrhage | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Paralysis | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Presenile dementia | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Ruptured cerebral aneurysm | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Vertebral artery stenosis | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Reversible ischaemic neurological deficit | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Thalamus haemorrhage | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Putamen haemorrhage | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Thrombotic cerebral infarction | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Amyotrophic lateral sclerosis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Carotid artery stenosis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Cerebellar haemorrhage | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Cervicobrachial syndrome | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Dysarthria | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Myelopathy | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Petit mal epilepsy | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Sciatica | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Vertebral artery occlusion | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Psychiatric disorders | ||||
| Delirium | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Anxiety disorder | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Anxiety | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Completed suicide | 1/1337 (0.1%) | 2/1335 (0.1%) | ||
| Suicide attempt | 1/1337 (0.1%) | 3/1335 (0.2%) | ||
| Alcoholism | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Depression | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Dissociative disorder | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Mania | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Adjustment disorder | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Renal and urinary disorders | ||||
| Calculus bladder | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Calculus ureteric | 1/1337 (0.1%) | 4/1335 (0.3%) | ||
| Calculus urethral | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Hydronephrosis | 1/1337 (0.1%) | 2/1335 (0.1%) | ||
| Nephrolithiasis | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Renal failure acute | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Bladder prolapse | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Acute prerenal failure | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Calculus urinary | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Glomerulonephritis rapidly progressive | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Haematuria | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Nephritis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Proteinuria | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Renal failure | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Urinary retention | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Renal impairment | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Uterine prolapse | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Prostatitis | 0/1337 (0%) | 2/1335 (0.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Pneumonia aspiration | 4/1337 (0.3%) | 2/1335 (0.1%) | ||
| Haemoptysis | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Haemothorax | 2/1337 (0.1%) | 1/1335 (0.1%) | ||
| Interstitial lung disease | 2/1337 (0.1%) | 1/1335 (0.1%) | ||
| Asthma | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Emphysema | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Nasal polyps | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Pulmonary embolism | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Diaphragmatic disorder | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Asphyxia | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Epistaxis | 0/1337 (0%) | 4/1335 (0.3%) | ||
| Nasal congestion | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Pleurisy | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Pneumothorax | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Status asthmaticus | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Upper respiratory tract inflammation | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Drug eruption | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Neurodermatitis | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Hypoaesthesia facial | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Skin mass | 0/1337 (0%) | 1/1335 (0.1%) | ||
| Vascular disorders | ||||
| Shock haemorrhagic | 2/1337 (0.1%) | 0/1335 (0%) | ||
| Aneurysm | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Aortic aneurysm | 1/1337 (0.1%) | 1/1335 (0.1%) | ||
| Aortic aneurysm rupture | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Varicose vein | 1/1337 (0.1%) | 3/1335 (0.2%) | ||
| Arteriosclerosis obliterans | 1/1337 (0.1%) | 0/1335 (0%) | ||
| Peripheral artery aneurysm | 0/1337 (0%) | 1/1335 (0.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Cilostazol | Aspirin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1267/1337 (94.8%) | 1260/1335 (94.4%) | ||
| Cardiac disorders | ||||
| Palpitations | 156/1337 (11.7%) | 71/1335 (5.3%) | ||
| Tachycardia | 89/1337 (6.7%) | 21/1335 (1.6%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 164/1337 (12.3%) | 85/1335 (6.4%) | ||
| Constipation | 110/1337 (8.2%) | 155/1335 (11.6%) | ||
| Dental caries | 93/1337 (7%) | 114/1335 (8.5%) | ||
| Periodontitis | 77/1337 (5.8%) | 64/1335 (4.8%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 546/1337 (40.8%) | 590/1335 (44.2%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 128/1337 (9.6%) | 121/1335 (9.1%) | ||
| Investigations | ||||
| Blood glucose increased | 92/1337 (6.9%) | 79/1335 (5.9%) | ||
| Blood pressure increased | 71/1337 (5.3%) | 88/1335 (6.6%) | ||
| Blood creatine phosphokinase increased | 67/1337 (5%) | 76/1335 (5.7%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus | 96/1337 (7.2%) | 75/1335 (5.6%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 160/1337 (12%) | 165/1335 (12.4%) | ||
| Arthralgia | 118/1337 (8.8%) | 102/1335 (7.6%) | ||
| Musculoskeletal pain | 73/1337 (5.5%) | 55/1335 (4.1%) | ||
| Nervous system disorders | ||||
| Headache | 312/1337 (23.3%) | 217/1335 (16.3%) | ||
| Dizziness | 124/1337 (9.3%) | 92/1335 (6.9%) | ||
| Psychiatric disorders | ||||
| Insomnia | 81/1337 (6.1%) | 96/1335 (7.2%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Upper respiratory tract inflammation | 97/1337 (7.3%) | 105/1335 (7.9%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Eczema | 97/1337 (7.3%) | 104/1335 (7.8%) | ||
| Vascular disorders | ||||
| Hypertension | 120/1337 (9%) | 185/1335 (13.9%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Masahiko Abe, Director Cardiovascular Projects |
|---|---|
| Organization | Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd. |
| Phone | +81-6-6943-7722 ext 2545 |
| abems@otsuka.jp |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00234065
Other Study ID Numbers:
- C02100-002
- JapicCTI-050034
- UMIN-CTR-C000000129
First Posted:
Oct 6, 2005
Last Update Posted:
Jun 10, 2011
Last Verified:
Jun 1, 2011