Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI)
Study Details
Study Description
Brief Summary
This Phase IV, multicenter trial is designed to assess the efficacy of prasugrel in preventing the formation of blood clots in Taiwanese patients with ACS who have been treated with PCI.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prasugrel Participants with ACS who underwent PCI, and were previously taking clopidogrel, receive a maintenance dose (MD) of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS underwent PCI) |
Drug: Prasugrel
Prasugrel, oral tablets, containing 3.75 mg per tablet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Change From Baseline to Week 4 in P2Y12 Reaction Units During Period 1 [Baseline up to Week 4 post-maintenance dose prasugrel treatment period]
The mean change in the P2Y12 reaction unit value assessed from baseline to the end of the 4-week maintenance dose treatment period, after switching from clopidogrel maintenance dose to prasugrel maintenance dose was analyzed with a paired t-test model. Mean changes (including standard deviations) are presented.
- Number of Participants With Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding Events During Period 2 [End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period]
All safety events were assessed in the overall Safety Population, regardless of the study period. The incidence of major bleeding events (defined as non-coronary artery bypass grafting [CABG] thrombolysis in myocardial infarction (TIMI) major) after 28 maintenance dose treatment weeks (optional maximum 12-month P2Y12 inhibitor treatment after ACS participants underwent PCI) are reported. Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days)
Secondary Outcome Measures
- Number of Participants With High On-Treatment Platelet Reactivity (HTPR) During Period 1 [Baseline up to Week 4 post-maintenance dose prasugrel treatment period]
High On-Treatment Platelet Reactivity (HTPR) was defined as PRU >235.
- Mean Percentage Change From Baseline to Week 4 in Platelet Inhibition During Period 1 [Baseline up to Week 4 post-maintenance dose prasugrel treatment period]
The mean percentage change in platelet inhibition at the end of the 4-week maintenance dose prasugrel treatment period, after switching from clopidogrel maintenance dose to prasugrel maintenance dose is reported.
- Number of Participants With Adverse Events of Special Interest During Period 1 [Baseline up to Week 4 post-maintenance dose prasugrel treatment period]
Adverse events of special interest were defined as major and minor bleeding events, clinically relevant bleeding events, and any major adverse cardiovascular events (MACE). Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days). Non-CABG TIMI minor bleeding was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to less than 5 g/dL.
- Number of Participants With Adverse Events of Special Interest During Period 2 [End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period]
All safety events were assessed in the overall Safety Population, regardless of the study period. Adverse events of special interest were defined as major and minor bleeding events, clinically relevant bleeding events, and any major adverse cardiovascular events (MACE). Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days). Non-CABG TIMI minor bleeding was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to less than 5 g/dL.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Is within the age limits and has signed informed consent
-
Weighs at least 50 kg
-
Had a previous diagnosis of ACS (UA, STEMI, or NSTEMI), underwent PCI, and received one of the following treatments:
-
Clopidogrel MD of 75 mg and aspirin 81-100 mg for 2-8 weeks following clopidogrel loading dose (LD) of 300 mg or 600 mg at the time of PCI
-
Ticagrelor MD of 90 mg twice daily (BID) and aspirin 81-100 mg for 1-4 weeks and switching to clopidogrel MD of 75 mg and aspirin 81-100 mg for 2-4 weeks following ticagrelor LD of 180 mg at the time of PCI
-
Clopidogrel MD 75 mg and aspirin 81-100 mg for 2-8 weeks following ticagrelor LD of 180 mg at the time of PCI
-
Or based on investigator's judgment with at least 2 weeks continued use of clopidogrel MD and aspirin 81-100 mg per day before switching to prasugrel and maximum 8 weeks P2Y12 inhibitors MD treatment (prasugrel is not allowed)
-
Is willing and able to abide by the rules of the research unit and study restrictions
-
If a woman of child-bearing potential, has a negative serum pregnancy test at screening
-
Agrees to use at least one method of contraception during the study
Exclusion Criteria:
-
Has active bleeding, significant risk of hemorrhage, or unusual susceptibility to bleed
-
Had previous hemorrhagic stroke at any time, or transient ischemic attack (TIA) or ischemic stroke within 3 months before the informed consent date
-
Has known allergies or hypersensitivity to prasugrel, aspirin, or any of their excipients
-
Has significant hypertension at screening or baseline assessment
-
Has hemoglobin levels <10.5 g/dL or hematocrit levels <30%
-
Has severe left ventricular systolic dysfunction, ejection fraction <30%
-
Is currently undergoing hemodialysis
-
Has evidence of severe hepatic disease or any of the following: serum alanine transaminase or aspartate transaminase ≥3 times the upper limit of normal (ULN); or bilirubin ≥2 times the ULN at screening
-
Has any clinical laboratory result performed at screening that is determined to be detrimental to the patient or could compromise the study as determined the Investigator
-
Has previously participated in this study or in another interventional trial that is not compatible with this study
-
Has evidence of significant active neuropsychiatric disease, alcohol abuse or drug abuse as determined by the Investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaohsiung Veterans General Hospital | Kaohsiung | Taiwan | ||
| 2 | China Medical University Hospital | Taichung | Taiwan | ||
| 3 | Taichung Veterans General Hospital | Taichung | Taiwan | ||
| 4 | National Cheng Kung University Hospital | Tainan | Taiwan | ||
| 5 | Cheng Hsin General Hospital | Taipei | Taiwan | ||
| 6 | Mackay Memorial Hospital | Taipei | Taiwan | ||
| 7 | National Taiwan University Hospital | Taipei | Taiwan | ||
| 8 | Taipei Veterans General Hospital | Taipei | Taiwan | ||
| 9 | Tri-Service General Hospital | Taipei | Taiwan | ||
| 10 | Chang Gung Memorial Hospital, Linkou | Taoyuan | Taiwan |
Sponsors and Collaborators
- Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
Investigators
- Study Director: Clinical Study Leader, Daiichi Sankyo, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.- CS747S-B-A4003
Study Results
Participant Flow
| Recruitment Details | A total of 204 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 10 clinic sites in Taiwan from 01 Nov 2018 to 19 Aug 2020. One patient did not receive study treatment. |
|---|---|
| Pre-assignment Detail | Participants with a previous diagnosis of acute coronary syndrome (ACS) who had undergone percutaneous coronary intervention (PCI) and had been previously treated with a maintenance dose of clopidogrel. |
| Arm/Group Title | Prasugrel |
|---|---|
| Arm/Group Description | Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI). |
| Period Title: Period 1 | |
| STARTED | 204 |
| COMPLETED | 200 |
| NOT COMPLETED | 4 |
| Period Title: Period 1 | |
| STARTED | 200 |
| COMPLETED | 196 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Prasugrel |
|---|---|
| Arm/Group Description | Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI). |
| Overall Participants | 203 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
130
64%
|
| >=65 years |
73
36%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
60.6
(10.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
19
9.4%
|
| Male |
184
90.6%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
203
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
0
0%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| Taiwan |
203
100%
|
Outcome Measures
| Title | Mean Change From Baseline to Week 4 in P2Y12 Reaction Units During Period 1 |
|---|---|
| Description | The mean change in the P2Y12 reaction unit value assessed from baseline to the end of the 4-week maintenance dose treatment period, after switching from clopidogrel maintenance dose to prasugrel maintenance dose was analyzed with a paired t-test model. Mean changes (including standard deviations) are presented. |
| Time Frame | Baseline up to Week 4 post-maintenance dose prasugrel treatment period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The P2Y12 reaction unit change from baseline was assessed in patients with available data in the Safety Population. |
| Arm/Group Title | Prasugrel |
|---|---|
| Arm/Group Description | Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI). |
| Measure Participants | 200 |
| Mean (Standard Deviation) [P2Y12 reaction unit] |
-18.2
(48.1)
|
| Title | Number of Participants With Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding Events During Period 2 |
|---|---|
| Description | All safety events were assessed in the overall Safety Population, regardless of the study period. The incidence of major bleeding events (defined as non-coronary artery bypass grafting [CABG] thrombolysis in myocardial infarction (TIMI) major) after 28 maintenance dose treatment weeks (optional maximum 12-month P2Y12 inhibitor treatment after ACS participants underwent PCI) are reported. Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days) |
| Time Frame | End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants with major bleeding events was assessed in the Safety Population. |
| Arm/Group Title | Prasugrel |
|---|---|
| Arm/Group Description | Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI). |
| Measure Participants | 203 |
| Count of Participants [Participants] |
4
2%
|
| Title | Number of Participants With High On-Treatment Platelet Reactivity (HTPR) During Period 1 |
|---|---|
| Description | High On-Treatment Platelet Reactivity (HTPR) was defined as PRU >235. |
| Time Frame | Baseline up to Week 4 post-maintenance dose prasugrel treatment period |
Outcome Measure Data
| Analysis Population Description |
|---|
| High On-Treatment Platelet Reactivity was assessed in the Safety Population. |
| Arm/Group Title | Prasugrel |
|---|---|
| Arm/Group Description | Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI). |
| Measure Participants | 203 |
| Baseline |
23
11.3%
|
| Week 4 |
6
3%
|
| Title | Mean Percentage Change From Baseline to Week 4 in Platelet Inhibition During Period 1 |
|---|---|
| Description | The mean percentage change in platelet inhibition at the end of the 4-week maintenance dose prasugrel treatment period, after switching from clopidogrel maintenance dose to prasugrel maintenance dose is reported. |
| Time Frame | Baseline up to Week 4 post-maintenance dose prasugrel treatment period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Platelet inhibition was assessed in participants with available data in the Safety Population. |
| Arm/Group Title | Prasugrel |
|---|---|
| Arm/Group Description | Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI). |
| Measure Participants | 200 |
| Mean (Standard Deviation) [percentage of platelet inhibition] |
7.2
(20.4)
|
| Title | Number of Participants With Adverse Events of Special Interest During Period 1 |
|---|---|
| Description | Adverse events of special interest were defined as major and minor bleeding events, clinically relevant bleeding events, and any major adverse cardiovascular events (MACE). Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days). Non-CABG TIMI minor bleeding was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to less than 5 g/dL. |
| Time Frame | Baseline up to Week 4 post-maintenance dose prasugrel treatment period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Adverse events of special interest were assessed in the Safety Population. |
| Arm/Group Title | Prasugrel |
|---|---|
| Arm/Group Description | Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI). |
| Measure Participants | 203 |
| Any major bleeding adverse events (AE) |
0
0%
|
| Any minor bleeding AE |
1
0.5%
|
| Any clinically relevant bleeding AE |
2
1%
|
| Any MACE, Cardiovascular death |
0
0%
|
| Any MACE, Non-fatal myocardial infarction |
0
0%
|
| Any MACE, Non-fatal stroke |
0
0%
|
| Any MACE, Stent thrombosis |
0
0%
|
| Any MACE, Revascularization |
0
0%
|
| Title | Number of Participants With Adverse Events of Special Interest During Period 2 |
|---|---|
| Description | All safety events were assessed in the overall Safety Population, regardless of the study period. Adverse events of special interest were defined as major and minor bleeding events, clinically relevant bleeding events, and any major adverse cardiovascular events (MACE). Non-CABG TIMI major bleeding was defined as any intracranial bleeding (excluding microhemorrhages less than 10 millimeter evident only on gradient-echo magnetic resonance imaging); clinically overt signs of hemorrhage associated with a drop in hemoglobin of greater than or equal to 5 g/dL; and fatal bleeding (bleeding that directly results in death within 7 days). Non-CABG TIMI minor bleeding was defined as clinically overt (including imaging), resulting in hemoglobin drop of 3 to less than 5 g/dL. |
| Time Frame | End of Week 4 up to Week 28 post-maintenance dose prasugrel treatment period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Adverse events of special interest were assessed in the Safety Population. |
| Arm/Group Title | Prasugrel |
|---|---|
| Arm/Group Description | Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI). |
| Measure Participants | 203 |
| Any major bleeding AE |
4
2%
|
| Any minor bleeding AE |
12
5.9%
|
| Any clinically relevant bleeding AE |
4
2%
|
| Any MACE, Cardiovascular death |
0
0%
|
| Any MACE, Non-fatal myocardial infarction |
2
1%
|
| Any MACE, Non-fatal stroke |
0
0%
|
| Any MACE, Stent thrombosis |
0
0%
|
| Any MACE, Revascularization |
0
0%
|
Adverse Events
| Time Frame | Adverse events were collected from the date of informed consent, and all adverse events which occurred after the first study medication intake and within 14 days after the treatment stop date was considered treatment emergent adverse events (TEAEs). | |
|---|---|---|
| Adverse Event Reporting Description | An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. | |
| Arm/Group Title | Prasugrel | |
| Arm/Group Description | Participants with ACS who underwent PCI, and were previously taking clopidogrel, who received a maintenance dose of prasugrel for a total of 28 weeks (optionally up to a maximum 12 months of P2Y12 inhibitor treatment after ACS participants underwent PCI). | |
All Cause Mortality |
||
| Prasugrel | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/203 (0.5%) | |
Serious Adverse Events |
||
| Prasugrel | ||
| Affected / at Risk (%) | # Events | |
| Total | 28/203 (13.8%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 1/203 (0.5%) | |
| Cardiac disorders | ||
| Angina pectoris | 2/203 (1%) | |
| Acute myocardial infarction | 2/203 (1%) | |
| Cardiac failure | 2/203 (1%) | |
| Cardiac failure acute | 1/203 (0.5%) | |
| Cardiac failure congestive | 1/203 (0.5%) | |
| Gastrointestinal disorders | ||
| Upper gastrointestinal haemorrhage | 2/203 (1%) | |
| Diarrhoea | 1/203 (0.5%) | |
| Duodenal ulcer | 1/203 (0.5%) | |
| Gastric ulcer haemorrhage | 1/203 (0.5%) | |
| Oesophageal ulcer haemorrhage | 1/203 (0.5%) | |
| General disorders | ||
| Chest pain | 1/203 (0.5%) | |
| Pyrexia | 1/203 (0.5%) | |
| Hepatobiliary disorders | ||
| Hepatitis acute | 2/203 (1%) | |
| Cholecystitis | 1/203 (0.5%) | |
| Hepatic mass | 1/203 (0.5%) | |
| Infections and infestations | ||
| Diverticulitis | 1/203 (0.5%) | |
| Pneumonia | 1/203 (0.5%) | |
| Injury, poisoning and procedural complications | ||
| Road traffic accident | 1/203 (0.5%) | |
| Skin abrasion | 1/203 (0.5%) | |
| Musculoskeletal and connective tissue disorders | ||
| Cervical spinal stenosis | 1/203 (0.5%) | |
| Intervertebral disc protrusion | 1/203 (0.5%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Bladder neoplasm | 1/203 (0.5%) | |
| Gastric cancer | 1/203 (0.5%) | |
| Rectosigmoid cancer | 1/203 (0.5%) | |
| Nervous system disorders | ||
| Dizziness | 1/203 (0.5%) | |
| Cerebral haemorrhage | 1/203 (0.5%) | |
| Tonic convulsion | 1/203 (0.5%) | |
| Renal and urinary disorders | ||
| Haematuria | 1/203 (0.5%) | |
| Hydronephrosis | 1/203 (0.5%) | |
| Vascular disorders | ||
| Peripheral arterial occlusive disease | 1/203 (0.5%) | |
Other (Not Including Serious) Adverse Events |
||
| Prasugrel | ||
| Affected / at Risk (%) | # Events | |
| Total | 125/203 (61.6%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 8/203 (3.9%) | |
| Thrombocytosis | 1/203 (0.5%) | |
| Cardiac disorders | ||
| Angina pectoris | 7/203 (3.4%) | |
| Acute myocardial infarction | 2/203 (1%) | |
| Atrial fibrillation | 2/203 (1%) | |
| Cardiac failure | 2/203 (1%) | |
| Cardiac failure acute | 1/203 (0.5%) | |
| Cardiac failure congestive | 1/203 (0.5%) | |
| Palpitations | 1/203 (0.5%) | |
| Sinus bradycardia | 1/203 (0.5%) | |
| Supraventricular extrasystoles | 1/203 (0.5%) | |
| Tachycardia | 1/203 (0.5%) | |
| Ventricular tachycardia | 1/203 (0.5%) | |
| Ear and labyrinth disorders | ||
| Vertigo | 1/203 (0.5%) | |
| Vestibular disorder | 1/203 (0.5%) | |
| Eye disorders | ||
| Vision blurred | 2/203 (1%) | |
| Ocular discomfort | 1/203 (0.5%) | |
| Gastrointestinal disorders | ||
| Abdominal pain upper | 4/203 (2%) | |
| Diarrhoea | 4/203 (2%) | |
| Abdominal discomfort | 3/203 (1.5%) | |
| Constipation | 3/203 (1.5%) | |
| Dental caries | 3/203 (1.5%) | |
| Gastrooesophageal reflux disease | 3/203 (1.5%) | |
| Abdominal distension | 2/203 (1%) | |
| Anal haemorrhage | 2/203 (1%) | |
| Gastric ulcer | 2/203 (1%) | |
| Gingival bleeding | 2/203 (1%) | |
| Upper gastrointestional haemorrhage | 2/203 (1%) | |
| Abdominal pain | 1/203 (0.5%) | |
| Duodenal ulcer | 1/203 (0.5%) | |
| Dyspepsia | 1/203 (0.5%) | |
| Gastric ulcer haemorrhage | 1/203 (0.5%) | |
| Gingival discomfort | 1/203 (0.5%) | |
| Haemorrhoidal haemorrhage | 1/203 (0.5%) | |
| Inguinal hernia | 1/203 (0.5%) | |
| Mouth ulceration | 1/203 (0.5%) | |
| Nausea | 1/203 (0.5%) | |
| Oesophageal ulcer haemorrhage | 1/203 (0.5%) | |
| Oral disorder | 1/203 (0.5%) | |
| Rectal haemorrhage | 1/203 (0.5%) | |
| Tooth pulp haemorrhage | 1/203 (0.5%) | |
| General disorders | ||
| Chest pain | 6/203 (3%) | |
| Chest discomfort | 5/203 (2.5%) | |
| Oedema peripheral | 3/203 (1.5%) | |
| Pyrexia | 2/203 (1%) | |
| Asthenia | 1/203 (0.5%) | |
| Non-cardiac chest pain | 1/203 (0.5%) | |
| Hepatobiliary disorders | ||
| Cholecystitis | 2/203 (1%) | |
| Hepatitis | 2/203 (1%) | |
| Hepatitis acute | 2/203 (1%) | |
| Hepatic mass | 1/203 (0.5%) | |
| Hyperbilirubinaemia | 1/203 (0.5%) | |
| Immune system disorders | ||
| Hypersensitivity | 1/203 (0.5%) | |
| Infections and infestations | ||
| Upper respiratory tract infection | 4/203 (2%) | |
| Conjunctivitis | 2/203 (1%) | |
| Influenza | 2/203 (1%) | |
| Body tinea | 1/203 (0.5%) | |
| Dermatophytosis of nail | 1/203 (0.5%) | |
| Diverticulitis | 1/203 (0.5%) | |
| Herpes virus infection | 1/203 (0.5%) | |
| Nasopharyngitis | 1/203 (0.5%) | |
| Periodontitis | 1/203 (0.5%) | |
| Pneumonia | 1/203 (0.5%) | |
| Tinea pedis | 1/203 (0.5%) | |
| Urinary tract infection | 1/203 (0.5%) | |
| Wound infection | 1/203 (0.5%) | |
| Injury, poisoning and procedural complications | ||
| Contusion | 4/203 (2%) | |
| Overdose | 3/203 (1.5%) | |
| Tendon injury | 2/203 (1%) | |
| Fracture | 1/203 (0.5%) | |
| Rib fracture | 1/203 (0.5%) | |
| Road traffic accident | 1/203 (0.5%) | |
| Skin abrasion | 1/203 (0.5%) | |
| Wound | 1/203 (0.5%) | |
| Investigations | ||
| Alanine aminotransferase increased | 3/203 (1.5%) | |
| Aspartate aminotransferase increased | 3/203 (1.5%) | |
| Liver function test abnormal | 3/203 (1.5%) | |
| Blood alkaline phosphatase increased | 2/203 (1%) | |
| Blood bilirubin increased | 2/203 (1%) | |
| Blood glucose increased | 1/203 (0.5%) | |
| Liver function test increased | 1/203 (0.5%) | |
| Low density lipoprotein increased | 1/203 (0.5%) | |
| Weight increased | 1/203 (0.5%) | |
| Metabolism and nutrition disorders | ||
| Gout | 1/203 (0.5%) | |
| Hyperkalaemia | 1/203 (0.5%) | |
| Hyperlipidaemia | 1/203 (0.5%) | |
| Hypocalcaemia | 1/203 (0.5%) | |
| Hypoglycaemia | 1/203 (0.5%) | |
| Hypokalaemia | 1/203 (0.5%) | |
| Musculoskeletal and connective tissue disorders | ||
| Myalgia | 3/203 (1.5%) | |
| Musculoskeletal pain | 2/203 (1%) | |
| Arthritis | 1/203 (0.5%) | |
| Cervical spinal stenosis | 1/203 (0.5%) | |
| Gouty arthritis | 1/203 (0.5%) | |
| Intervertebral disc protrusion | 1/203 (0.5%) | |
| Joint range of motion decreased | 1/203 (0.5%) | |
| Muscle spasms | 1/203 (0.5%) | |
| Neck pain | 1/203 (0.5%) | |
| Pain in extremity | 1/203 (0.5%) | |
| Spinal osteoarthritis | 1/203 (0.5%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Basal cell carcinoma | 1/203 (0.5%) | |
| Benign neoplasm | 1/203 (0.5%) | |
| Bladder neoplasm | 1/203 (0.5%) | |
| Gastric cancer | 1/203 (0.5%) | |
| Rectosigmoid cancer | 1/203 (0.5%) | |
| Skin papilloma | 1/203 (0.5%) | |
| Nervous system disorders | ||
| Dizziness | 6/203 (3%) | |
| Hypoaesthesia | 3/203 (1.5%) | |
| Poor quality sleep | 2/203 (1%) | |
| Syncope | 2/203 (1%) | |
| Cerebral haemorrhage | 1/203 (0.5%) | |
| Diabetic neuropathy | 1/203 (0.5%) | |
| Dizziness postural | 1/203 (0.5%) | |
| Headache | 1/203 (0.5%) | |
| Tonic convulsion | 1/203 (0.5%) | |
| Psychiatric disorders | ||
| Insomnia | 2/203 (1%) | |
| Renal and urinary disorders | ||
| Haematuria | 4/203 (2%) | |
| Chronic kidney disease | 2/203 (1%) | |
| Nocturia | 2/203 (1%) | |
| Acute kidney injury | 1/203 (0.5%) | |
| Calculus bladder | 1/203 (0.5%) | |
| Dysuria | 1/203 (0.5%) | |
| Hydronephrosis | 1/203 (0.5%) | |
| Nephritis | 1/203 (0.5%) | |
| Pollakiuria | 1/203 (0.5%) | |
| Renal failure | 1/203 (0.5%) | |
| Renal impairment | 1/203 (0.5%) | |
| Reproductive system and breast disorders | ||
| Breast tenderness | 2/203 (1%) | |
| Benign prostatic hyperplasia | 1/203 (0.5%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnoea | 5/203 (2.5%) | |
| Cough | 4/203 (2%) | |
| Rhinitis Allergic | 4/203 (2%) | |
| Dyspnoea exertional | 3/203 (1.5%) | |
| Epistaxis | 2/203 (1%) | |
| Acute pulmonary oedema | 1/203 (0.5%) | |
| Chronic obstructive pulmonary disease | 1/203 (0.5%) | |
| Nasal septum deviation | 1/203 (0.5%) | |
| Nasal turbinate hypertrophy | 1/203 (0.5%) | |
| Pulmonary fibrosis | 1/203 (0.5%) | |
| Skin and subcutaneous tissue disorders | ||
| Ecchymosis | 7/203 (3.4%) | |
| Dermatitis | 3/203 (1.5%) | |
| Rash | 2/203 (1%) | |
| Pruritus | 1/203 (0.5%) | |
| Surgical and medical procedures | ||
| Tooth extraction | 2/203 (1%) | |
| Stent placement | 1/203 (0.5%) | |
| Vascular disorders | ||
| Haematoma | 1/203 (0.5%) | |
| Haemorrhage | 1/203 (0.5%) | |
| Peripheral arterial occlusive disease | 1/203 (0.5%) | |
Limitations/Caveats
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 | Contact for Clinical Trial Information |
|---|---|
| Organization | Daiichi Sankyo |
| Phone | 908-992-6400 |
| CTRinfo@dsi.com |
- CS747S-B-A4003