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| ID | Type | Description | Link |
|---|---|---|---|
| H7T-MC-TABY(b) | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Daiichi Sankyo Co., Ltd. | INDUSTRY |
| Duke Clinical Research Institute | OTHER |
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This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).
Based upon the significant number of subjects with UA/NSTEMI ACS who are managed medically and their high risk for future cardiovascular events, further exploration of novel treatment strategies for this population, who are under-represented in large clinical trials, is warranted. Potential subjects will be those with a recent UA/NSTEMI event who are to be medically managed. Eligibility for this study will be determined by both the timing of the medical management decision and by prior commercial clopidogrel treatment at the time of randomization. The TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) Study will assess the efficacy and safety of prasugrel and aspirin compared to the current standard of care, clopidogrel and aspirin, for long-term treatment of medically managed UA/NSTEMI ACS subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel | Experimental | Prasugrel and Low-dose Commercially-available Aspirin |
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| Clopidogrel | Active Comparator | Clopidogrel and Low-Dose Commercially-available Aspirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | 300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke | The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. | Randomization through end of study (30-month visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Composite Endpoint of CV Death and MI | The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee. | Randomization through end of study (30-month visit) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Birmingham | Alabama | 35233 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35224730 | Derived | Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4. | |
| 32862694 | Derived | Marquis-Gravel G, Neely ML, Valgimigli M, Costa F, Van Klaveren D, Altner R, Bhatt DL, Armstrong PW, Fox KAA, White HD, Ohman EM, Roe MT. Long-Term Bleeding Risk Prediction with Dual Antiplatelet Therapy After Acute Coronary Syndromes Treated Without Revascularization. Circ Cardiovasc Qual Outcomes. 2020 Sep;13(9):e006582. doi: 10.1161/CIRCOUTCOMES.120.006582. Epub 2020 Aug 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prasugrel: <75 Years of Age | Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Prasugrel | Drug | 30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study |
|
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| Commercially-available Aspirin | Drug | Low-dose aspirin, oral, as prescribed by physician through end of study |
|
| Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA) | The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee. | Randomization through end of study (30-month visit) |
| Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke | The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee. | Randomization through end of study (30-month visit) |
| Platelet Aggregation Measures | Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization. | Day 30 and 12 Months |
| Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP) | Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization. | Day 30 and 6 Months |
| Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP) | C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization. | Day 30 and Month 6 |
| Genotyping Related to Drug Metabolism | Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100. | Baseline |
| Economic and Quality of Life Outcomes | Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life. | Baseline and follow-up (24 months) |
| Summary of All Deaths | All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module. | Randomization through end of study (30-month visit) |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Huntsville | Alabama | 35801 | United States |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Caba | C1180AAX | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Concordia | E3202BQF | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Corrientes | 3400 | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Córdoba | X5000JHQ | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Formosa | 3606 | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Godoy Cruz | 5501 | Argentina |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mar del Plata | B7600FZD | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Morón | B1708KCH | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rosario | S2002KDS | Argentina |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santa Fe | S3000FUJ | Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Villa Cabrera | S5009BSN | Argentina |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Coffs Harbour | New South Wales | 2450 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lismore | New South Wales | 2480 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Newcastle | New South Wales | 2305 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wollongong | New South Wales | 2500 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Herston | Queensland | 4029 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nambour | Queensland | 4560 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Redcliffe | Queensland | 4020 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Southport | Queensland | 4215 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bedford Park | South Australia | 5042 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Elizabeth Vale | South Australia | 5112 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hobart | Tasmania | 7000 | Australia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Feldkirch | 6807 | Austria |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vienna | 1100 | Austria |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brussels | 1200 | Belgium |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mol | 2400 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Overpelt | 3900 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aracaju | 49015-400 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Belo Horizonte | 30380-090 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Blumenau | 89010-500 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brasília | 70658-700 | Brazil |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Campinas | 13010-001 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Campo Grande | 79080-190 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Caxias do Sul | 95070560 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Curitiba | 80010-030 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dois Lajeados | 95900-000 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Goiânia | 74223-130 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Maceió | 57021-500 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Maringá | 87015-290 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Passo Fundo | 99010-080 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Piracicaba | 13405-126 | Brazil |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recife | 52051-380 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ribeirão Preto | 14048-900 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rio de Janeiro | 21041-030 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Salvador | 41144900 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santo André | 09190-610 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sao Jose Rio Preto | 15090-000 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | São Caetano do Sul | 09540-400 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | São José | 88103-460 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | São Paulo | 05017000 | Brazil |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Uberlândia | 38400-368 | Brazil |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Edmonton | Alberta | T6K 4C1 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Campbell River | British Columbia | V9W 5Y4 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ajax | Ontario | L1S 2J5 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Burlington | Ontario | L7M 4Y1 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cambridge | Ontario | N1R 7R1 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Greater Sudbury | Ontario | P3E 2N8 | Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | London | Ontario | N6A 5A5 | Canada |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sarnia | Ontario | N7T 4R9 | Canada |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jiangsu | 210009 | China |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Varaždin | 42 000 | Croatia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Zadar | 23000 | Croatia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Zagreb | 10000 | Croatia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Děčín | 405 99 | Czechia |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hradec Králové | 500 05 | Czechia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Karlovy Vary | 360 66 | Czechia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kroměříž | 767 55 | Czechia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Liberec | 460 03 | Czechia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nový Jičín | 74101 | Czechia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pardubice | 532 03 | Czechia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Prague | 140 21 | Czechia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Zlín | 76275 | Czechia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Copenhagen | 2300 | Denmark |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Copenhagen | 2400 | Denmark |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hellerup | 2900 | Denmark |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Alexandria | 21131 | Egypt |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Beni Sweif | Egypt |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cairo | Egypt |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ismailia | Egypt |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Menoufiya | Egypt |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jyväskylä | 40620 | Finland |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Angers | 49933 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Arras | 62000 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Besançon | 25030 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cambrai | 59407 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chartres | 28018 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dijon | 21079 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Douai | 59507 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | La Roche-sur-Yon | 85025 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lagny-sur-Marne | 77405 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nantes | 44277 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nice | 06002 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Paris | 75015 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pessac | 33604 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Poitiers | 86021 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Strasbourg | 67091 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Toulouse | 31059 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valenciennes | 59322 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vandœuvre-lès-Nancy | 54511 | France |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bad Nauheim | 61231 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cologne | 50968 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Darmstadt | 64283 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dortmund | 44137 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Frankfurt | 65929 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Halle | 06120 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Idar-Oberstein | 55743 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leipzig | 04289 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mainz | 55131 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mannheim | 68167 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Stuttgart | 70376 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tübingen | 72076 | Germany |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Athens | 16673 | Greece |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Haidari/Athens | 12462 | Greece |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Magoula | 19600 | Greece |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pátrai | 26504 | Greece |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rhodes | 85100 | Greece |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Trikala | 42100 | Greece |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Baja | 6500 | Hungary |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Békéscsaba | 5601 | Hungary |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Budapest | 1125 | Hungary |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kalocsa | 6300 | Hungary |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kecskemét | 6000 | Hungary |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Komárom | 2921 | Hungary |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Miskolc | H-3529 | Hungary |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sátoraljaújhely | H-3980 | Hungary |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sopron | 9400 | Hungary |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Szekszárd | 7100 | Hungary |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ahmedabad | 382 428 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Anand | 388325 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aurangabad | 431001 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bangalore | 560034 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bārāmati | 413102 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bikaner | 334003 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Calicut | 673004 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chidambaram | 608002 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Coimbatore | 641004 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ernākulam | 683577 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Guntur | 522001 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gurgaon | 122001 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hyderabaad | 500001 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indore | 452018 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jaipur | 302017 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jalandhar | 144008 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kochi | 683572 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kolkata | 700091 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kottayam | 686016 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lucknow | 226003 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madurai | 625020 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mumbai | 400012 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mysore | 570004 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nagpur | 440033 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nashik | 422005 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | New Delhi | 110015 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Patiāla | 147001 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pune | 411033 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sāket | 110017 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Secunderabad | 500 003 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shivamogga | 577201 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Solapur | 413003 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Surat | 395007 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Thrissur | 680002 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tirupati | 517 507 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Trivandrum | 695002 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vadodara | 390015 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vijayawada | 520008 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Visakhapatnam | 530 003 | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dublin | Ireland |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Galway | Ireland |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Afula | 18101 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ashkelon | 78278 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Beersheba | 84101 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Eilat | 88104 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Haifa | 31096 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jerusalem | 91240 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kfar Saba | 44281 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nahariya | 22100 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nazareth | 16100 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rehovot | 76100 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tel Aviv | 64239 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tel Litwinsky | 52621 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tiberias | 15208 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tzfat | 13100 | Israel |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Albano Laziale | 00041 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ascoli Piceno | 63100 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bari | 70124 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bergamo | 24128 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brescia | 25127 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Caserta | 81100 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Forlì | 47100 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lecco | 23900 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Legnago | 37045 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Legnano | 20025 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Milan | 20162 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Novara | 28100 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Parma | 43100 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Perugia | 06156 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pescara | 65124 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Reggio Emilia | 42100 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rimini | 47900 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rome | 00161 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Daniele del Friuli | 33038 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santa Maria Capua Vetere | 81055 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saronno | 21047 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sorrento | 80067 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Terni | 5100 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Trieste | 34142 | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaunas | LT-50009 | Lithuania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Klaipėda | 92288 | Lithuania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Šiauliai | 73231 | Lithuania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vilnius | LT-08661 | Lithuania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cheras, Kuala Lumpur | 56000 | Malaysia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Johor Bahru | 80100 | Malaysia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kelantan | 16150 | Malaysia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kuala Lumpur | 59100 | Malaysia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kuala Selangor | 43300 | Malaysia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kuantan Pahang | 25100 | Malaysia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Perak | 30990 | Malaysia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sarawak | 93586 | Malaysia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Taiping Perak | 34000 | Malaysia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gozo | VCT102 | Malta |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Msida | 2090 | Malta |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aguascalientes | 20230 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Culiacán | 80270 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Durango | 340000 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jalisco | 44210 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | León | 37660 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Monterrey | 64020 | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Puebla City | 72490 | Mexico |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Colchester | Essex | C04 5JL | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Romford | Essex | RM7 0AG | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | London | Greater London | SE13 6LH | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Southall | Greater London | UB1 3HW | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Newport | Gwent | NP20 2UB | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Portsmouth | Hampshire | P06 3LY | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Orpington | Kent | BR6 8ND | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lincoln | Lincolnshire | LN2 5QY | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Metropolitan Borough of Wirral | Merseyside | CH49 5PE | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | York | North Yorkshire | YO31 8HE | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nottingham | Nottinghamshire | NG5 1PD | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Yeovil | Somerset | BA21 4AT | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sunderland | Sunderland | SR4 7TP | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dundee | Tays | DD1 9SY | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nuneaton | Warwickshire | CV10 7BL | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Warwick | Warwickshire | CV34 5BW | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Livingston | West Lothian | EH54 6PP | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Birmingham | West Midlands | B75 7RR | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Dudley | West Midlands | DY1 2HQ | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | West Bromwich | West Midlands | B71 4HJ | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wolverhampton | West Midlands | WV10 0QP | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Northampton | NN1 5BD | United Kingdom |
| 30935633 | Derived | Kaul P, Alexander KP, Ohman EM, Savu A, Roe MT, Goodman SG, Fox KA, White HD, Prabhakaran D, Hochman JS, Clemmensen P, Armstrong PW. Sex And Prognostic Significance of Self-Reported Frailty in Non-ST-Segment Elevation Acute Coronary Syndromes: Insights From the TRILOGY ACS Trial. Can J Cardiol. 2019 Apr;35(4):430-437. doi: 10.1016/j.cjca.2018.12.035. Epub 2018 Dec 31. |
| 30562068 | Derived | Fanaroff AC, Cyr D, Neely ML, Bakal J, White HD, Fox KAA, Armstrong PW, Lopes RD, Ohman EM, Roe MT. Days Alive and Out of Hospital: Exploring a Patient-Centered, Pragmatic Outcome in a Clinical Trial of Patients With Acute Coronary Syndromes. Circ Cardiovasc Qual Outcomes. 2018 Dec;11(12):e004755. doi: 10.1161/CIRCOUTCOMES.118.004755. |
| 29910052 | Derived | Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28. |
| 28515099 | Derived | Chan MY, Neely ML, Roe MT, Goodman SG, Erlinge D, Cornel JH, Winters KJ, Jakubowski JA, Zhou C, Fox KAA, Armstrong PW, White HD, Prabhakaran D, Ohman EM, Huber K; TRILOGY ACS Investigators. Temporal Biomarker Profiling Reveals Longitudinal Changes in Risk of Death or Myocardial Infarction in Non-ST-Segment Elevation Acute Coronary Syndrome. Clin Chem. 2017 Jul;63(7):1214-1226. doi: 10.1373/clinchem.2016.265272. Epub 2017 May 17. |
| 28400368 | Derived | Goldstein SA, Newby LK, Cyr DD, Neely M, Luscher TF, Brown EB, White HD, Ohman EM, Roe MT, Hamm CW. Relationship Between Peak Troponin Values and Long-Term Ischemic Events Among Medically Managed Patients With Acute Coronary Syndromes. J Am Heart Assoc. 2017 Apr 11;6(4):e005334. doi: 10.1161/JAHA.116.005334. |
| 28381584 | Derived | Alfredsson J, Neely B, Neely ML, Bhatt DL, Goodman SG, Tricoci P, Mahaffey KW, Cornel JH, White HD, Fox KA, Prabhakaran D, Winters KJ, Armstrong PW, Ohman EM, Roe MT; TRILOGY ACS Investigators. Predicting the risk of bleeding during dual antiplatelet therapy after acute coronary syndromes. Heart. 2017 Aug;103(15):1168-1176. doi: 10.1136/heartjnl-2016-310090. Epub 2017 Apr 5. |
| 27815268 | Derived | Cornel JH, Ohman EM, Neely B, Jakubowski JA, Bhatt DL, White HD, Ardissino D, Fox KA, Prabhakaran D, Armstrong PW, Erlinge D, Tantry US, Gurbel PA, Roe MT. Relationship of Platelet Reactivity With Bleeding Outcomes During Long-Term Treatment With Dual Antiplatelet Therapy for Medically Managed Patients With Non-ST-Segment Elevation Acute Coronary Syndromes. J Am Heart Assoc. 2016 Nov 4;5(11):e003977. doi: 10.1161/JAHA.116.003977. |
| 27030601 | Derived | Chin CT, Boden WE, Roe MT, Neely B, Neely ML, Leiva-Pons JL, Corbalan R, Gottlieb S, Dalby AJ, Armstrong PW, Prabhakaran D, Fox KA, White HD, Ohman EM, Winters KJ, Schiele F. Effect of prior clopidogrel use on outcomes in medically managed acute coronary syndrome patients. Heart. 2016 Aug 1;102(15):1221-9. doi: 10.1136/heartjnl-2015-308840. Epub 2016 Mar 30. |
| 26988949 | Derived | Lopes RD, Leonardi S, Neely B, Neely ML, Ohman EM, Ardissino D, Hamm CW, Goodman SG, Bhatt DL, White HD, Prabhakaran D, Martinez F, Nicolau JC, Winters KJ, Fox KA, Armstrong PW, Roe MT. Spontaneous MI After Non-ST-Segment Elevation Acute Coronary Syndrome Managed Without Revascularization: The TRILOGY ACS Trial. J Am Coll Cardiol. 2016 Mar 22;67(11):1289-97. doi: 10.1016/j.jacc.2016.01.034. |
| 26916483 | Derived | Doll JA, Neely ML, Roe MT, Armstrong PW, White HD, Prabhakaran D, Winters KJ, Duvvuru S, Sundseth SS, Jakubowski JA, Gurbel PA, Bhatt DL, Ohman EM, Fox KAA; TRILOGY ACS Investigators. Impact of CYP2C19 Metabolizer Status on Patients With ACS Treated With Prasugrel Versus Clopidogrel. J Am Coll Cardiol. 2016 Mar 1;67(8):936-947. doi: 10.1016/j.jacc.2015.12.036. |
| 26883498 | Derived | Chin CT, Neely B, Magnus Ohman E, Armstrong PW, Corbalan R, White HD, Prabhakaran D, Winters KJ, Fox KA, Roe MT; TRILOGY ACS Investigators. Time-Varying Effects of Prasugrel Versus Clopidogrel on the Long-Term Risks of Stroke After Acute Coronary Syndromes: Results From the TRILOGY ACS Trial. Stroke. 2016 Apr;47(4):1135-9. doi: 10.1161/STROKEAHA.115.012454. Epub 2016 Feb 16. |
| 26637834 | Derived | Roe MT, Cyr DD, Eckart D, Schulte PJ, Morse MA, Blackwell KL, Ready NE, Zafar SY, Beaven AW, Strickler JH, Onken JE, Winters KJ, Houterloot L, Zamoryakhin D, Wiviott SD, White HD, Prabhakaran D, Fox KA, Armstrong PW, Ohman EM; TRILOGY ACS Investigators. Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome. Eur Heart J. 2016 Jan 21;37(4):412-22. doi: 10.1093/eurheartj/ehv611. Epub 2015 Dec 5. |
| 26386793 | Derived | Clemmensen P, Roe MT, Hochman JS, Cyr DD, Neely ML, McGuire DK, Cornel JH, Huber K, Zamoryakhin D, White HD, Armstrong PW, Fox KA, Prabhakaran D, Ohman EM; TRILOGY ACS Investigators. Long-term outcomes for women versus men with unstable angina/non-ST-segment elevation myocardial infarction managed medically without revascularization: insights from the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes trial. Am Heart J. 2015 Oct;170(4):695-705.e5. doi: 10.1016/j.ahj.2015.06.011. Epub 2015 Jun 20. |
| 26089177 | Derived | Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512. |
| 25538134 | Derived | Roy A, Roe MT, Neely ML, Cyr DD, Zamoryakhin D, Fox KA, White HD, Armstrong PW, Ohman EM, Prabhakaran D. Impact of Human Development Index on the profile and outcomes of patients with acute coronary syndrome. Heart. 2015 Feb;101(4):279-86. doi: 10.1136/heartjnl-2014-306389. Epub 2014 Dec 23. |
| 25012156 | Derived | Bakal JA, Roe MT, Ohman EM, Goodman SG, Fox KA, Zheng Y, Westerhout CM, Hochman JS, Lokhnygina Y, Brown EB, Armstrong PW. Applying novel methods to assess clinical outcomes: insights from the TRILOGY ACS trial. Eur Heart J. 2015 Feb 7;36(6):385-92a. doi: 10.1093/eurheartj/ehu262. Epub 2014 Jul 10. |
| 24952863 | Derived | Cornel JH, Ohman EM, Neely B, Clemmensen P, Sritara P, Zamoryakhin D, Armstrong PW, Prabhakaran D, White HD, Fox KA, Gurbel PA, Roe MT; TRILOGY ACS Investigators. Impact of smoking status on platelet function and clinical outcomes with prasugrel vs. clopidogrel in patients with acute coronary syndromes managed without revascularization: Insights from the TRILOGY ACS trial. Am Heart J. 2014 Jul;168(1):76-87.e1. doi: 10.1016/j.ahj.2014.04.011. Epub 2014 Apr 24. |
| 23953385 | Derived | Wiviott SD, White HD, Ohman EM, Fox KA, Armstrong PW, Prabhakaran D, Hafley G, Lokhnygina Y, Boden WE, Hamm C, Clemmensen P, Nicolau JC, Menozzi A, Ruzyllo W, Widimsky P, Oto A, Leiva-Pons J, Pavlides G, Winters KJ, Roe MT, Bhatt DL. Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial. Lancet. 2013 Aug 17;382(9892):605-13. doi: 10.1016/S0140-6736(13)61451-8. |
| 23117779 | Derived | Gurbel PA, Erlinge D, Ohman EM, Neely B, Neely M, Goodman SG, Huber K, Chan MY, Cornel JH, Brown E, Zhou C, Jakubowski JA, White HD, Fox KA, Prabhakaran D, Armstrong PW, Tantry US, Roe MT; TRILOGY ACS Platelet Function Substudy Investigators. Platelet function during extended prasugrel and clopidogrel therapy for patients with ACS treated without revascularization: the TRILOGY ACS platelet function substudy. JAMA. 2012 Nov 7;308(17):1785-94. doi: 10.1001/jama.2012.17312. |
| 22920930 | Derived | Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG, Cornel JH, Bhatt DL, Clemmensen P, Martinez F, Ardissino D, Nicolau JC, Boden WE, Gurbel PA, Ruzyllo W, Dalby AJ, McGuire DK, Leiva-Pons JL, Parkhomenko A, Gottlieb S, Topacio GO, Hamm C, Pavlides G, Goudev AR, Oto A, Tseng CD, Merkely B, Gasparovic V, Corbalan R, Cinteza M, McLendon RC, Winters KJ, Brown EB, Lokhnygina Y, Aylward PE, Huber K, Hochman JS, Ohman EM; TRILOGY ACS Investigators. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med. 2012 Oct 4;367(14):1297-309. doi: 10.1056/NEJMoa1205512. Epub 2012 Aug 25. |
| 22783896 | Derived | Jeong YH, Tantry US, Gurbel PA. Importance of potent P2Y(12) receptor blockade in acute myocardial infarction: focus on prasugrel. Expert Opin Pharmacother. 2012 Aug;13(12):1771-96. doi: 10.1517/14656566.2012.704909. Epub 2012 Jul 12. |
| 20598967 | Derived | Chin CT, Roe MT, Fox KA, Prabhakaran D, Marshall DA, Petitjean H, Lokhnygina Y, Brown E, Armstrong PW, White HD, Ohman EM; TRILOGY ACS Steering Committee. Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non-ST-segment elevation myocardial infarction: the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial. Am Heart J. 2010 Jul;160(1):16-22.e1. doi: 10.1016/j.ahj.2010.04.022. |
| FG001 | Prasugrel: 75 Years of Age or Older | Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. |
| FG002 | Clopidogrel: <75 Years of Age | Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study |
| FG003 | Clopidogrel: 75 Years of Age or Older | Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prasugrel: <75 Years of Age | Prasugrel and Low-dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel : 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight) orally, once daily as maintenance dose through end of study. |
| BG001 | Prasugrel: 75 Years of Age or Older | Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. |
| BG002 | Clopidogrel: <75 Years of Age | Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
| BG003 | Clopidogrel: 75 Years of Age or Older | Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| History of Diabetes | Number | participants |
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| History of Myocardial Infarction (MI) | Number | participants |
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| History of Coronary Revascularization (PCI or CABG) | History of Coronary Revascularization due to percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) | Number | participants |
| |||||||||||||||
| Clinical Presentation of UA or NSTEMI | Clinical Presentation of unstable angina (UA) or non-ST-segment elevation myocardial infarction (NSTEMI) | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke | The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee. | All randomized participants | Posted | Number | percentage of participants with an event | Randomization through end of study (30-month visit) |
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| Secondary | Percentage of Participants With a Composite Endpoint of CV Death and MI | The percentage of participants is the total number of participants experiencing a CV death or nonfatal MI divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee. | All randomized participants | Posted | Number | percentage of participants with an event | Randomization through end of study (30-month visit) |
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| Secondary | Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA) | The percentage of participants is the total number of participants experiencing a CV death, nonfatal MI, nonfatal stroke or re-hospitalization for a recurrent UA divided by number of participants in the treatment arm. Endpoints events were adjudicated by the Clinical Endpoint Committee. | All randomized participants | Posted | Number | percentage of participants with an event | Randomization through end of study (30-month visit) |
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| Secondary | Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke | The percentage of participants is the total number of participants experiencing an all-cause death, nonfatal MI, or nonfatal stroke divided by number of participants in the treatment arm. Endpoint events were adjudicated by the Clinical Endpoint Committee. | All randomized participants | Posted | Number | percentage of participants with an event | Randomization through end of study (30-month visit) |
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| Secondary | Platelet Aggregation Measures | Platelet aggregation was measured by as measured by Accumetrics Verify Now™ P2Y12. Results were reported in P2Y12 Reaction Units (PRU). PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. Lower values indicate greater P2Y12 platelet inhibition and lower platelet activity and aggregation. ANCOVA Model was used and values were corrected for treatment + baseline value + clopidogrel status at randomization. | All participants who received at least 1 dose of study drug, and had a baseline and post-baseline PRU measurement at Day 30 or Month 12. | Posted | Least Squares Mean | Standard Error | P2Y12 Reaction Units (PRU) | Day 30 and 12 Months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP) | Brain natriuretic peptide (BNP) is secreted by the ventricles of the heart in response to hemodynamic stress and is a biomarker associated with increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization. | All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline BNP measurement at Day 30 or 6 Months. | Posted | Geometric Mean | Standard Error | picograms per milliliter (pg/mL) | Day 30 and 6 Months |
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| Secondary | Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP) | C-Reactive Protein (CRP) is a biomarker associated with inflammation and increased CV risk. Results are presented as geometric least squares means (Geometric LS means). Geometric LS means were adjusted for treatment + baseline value + clopidogrel status at randomization. | All randomized participants who received at least 1 dose of study therapy and had baseline and post-baseline CRP measurement at Day 30 or 6 Months. | Posted | Geometric Mean | Standard Error | milligrams per liter (mg/L) | Day 30 and Month 6 |
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| Secondary | Genotyping Related to Drug Metabolism | Variation in the genes encoding the cytochrome P450 (CYP) enzymes (CYP2C19) can reduce the ability to metabolize clopidogrel and a reduced platelet response and have been associated with increased rates of CV events including CV death. Participants were classified as extensive metabolizers (EM); reduced metabolizers (RM); or unknown (UNK) metabolizers based on their CYP2C19 genotype. Possible extensive metabolizer (EM) phenotypes include EM=extensive metabolizer, UM=ultra-rapid metabolizer, and EM (non-UM) that are not UM. Possible reduced metabolizer (RM) phenotypes include IM=intermediate metabolizer and PM=poor metabolizer. Genotypes associated with each predicted phenotype are presented; predicted phenotype is presented first followed by the genotype. Percentage=(number of participants with the predicted phenotype and genotype divided by the total number of participants per arm) multiplied by 100. | All randomized participants who provided a DNA sample. | Posted | Number | percentage participants with geneotype | Baseline |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Economic and Quality of Life Outcomes | Seattle Angina Questionnaire (SAQ) is a validated, disease-specific questionnaire containing 11 questions (Q) yielding 5 summary scales related to angina: physical limitations, angina stability, angina frequency, treatment satisfaction and disease perception. In this study only angina frequency and the physical limitations scales were assessed. Anginal Frequency was assessed using Q3 and Q4 which consists of a Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how often a patient is having symptoms now. Physical limitations was assessed using Q1 which contains 9 items each assessed via Likert scale ranging from 1 to 6 (higher values equals better quality of life) to assess how much a participant's condition is hampering their ability to do what they want to do. Scale scores are transformed to a 0-100 by subtracting the lowest possible score, dividing by the range of the scale, and multiplying by 100. Higher values equal better quality of life. | All randomized participants (combined <75 years and 75 years and older) with SAQ data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and follow-up (24 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Summary of All Deaths | All deaths, regardless of possible relatedness, with the exception of 1 event, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table. The 1 event which was not adjudicated was a result of the revocation of consent by the participant prior to their death. Deaths possibly related to study drug in the opinion of the investigator are also contained in the Serious Adverse Event (SAE) module. | All randomized participants | Posted | Number | participants | Randomization through end of study (30-month visit) |
|
Not provided
Events leading to death, MI, stroke, stent thrombosis, or rehospitalization for recurrent UA were not recorded as an SAEs unless the event was possibly due to study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prasugrel | Prasugrel and Low-dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study. | 1,573 | 4,623 | 2,581 | 4,623 | ||
| EG001 | Clopidogrel | Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. | 1,594 | 4,617 | 2,494 | 4,617 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anaemia haemolytic autoimmune | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Autoimmune thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Red blood cell abnormality | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arteriospasm coronary | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bradyarrhythmia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac flutter | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac valve disease | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Coronary artery dissection | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Coronary artery perforation | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Coronary artery thrombosis | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Low cardiac output syndrome | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Myocardial fibrosis | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Postinfarction angina | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ventricle rupture | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Branchial cyst | Congenital, familial and genetic disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastrointestinal angiodysplasia | Congenital, familial and genetic disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Glucose-6-phosphate dehydrogenase deficiency | Congenital, familial and genetic disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Primary hyperaldosteronism | Endocrine disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Primary hypothyroidism | Endocrine disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Amaurosis | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Corneal oedema | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Open angle glaucoma | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ophthalmoplegia | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Retinal vein thrombosis | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Duodenal polyp | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Erosive duodenitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Femoral hernia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastric disorder | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastric ulcer, obstructive | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastrointestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemorrhagic erosive gastritis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Inguinal hernia strangulated | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intestinal angina | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intestinal mass | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Mallory-weiss syndrome | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Mesenteric artery embolism | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Oesophageal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Palatal oedema | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pancreatitis haemorrhagic | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pancreatitis relapsing | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sigmoiditis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Euthanasia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Necrosis | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ulcer haemorrhage | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Biliary tract disorder | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hyperplastic cholecystopathy | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atopy | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Immunosuppression | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Burkholderia cepacia complex infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Burkholderia pseudomallei infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Eczema infected | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Enterocolitis bacterial | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Hepatitis b | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Hepatitis c | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Herpes zoster ophthalmic | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Infectious peritonitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Mediastinitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Meningitis tuberculous | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Osteomyelitis chronic | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Parametritis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Peridiverticular abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pyonephrosis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Viral diarrhoea | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Chemical burns of eye | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Confusion postoperative | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Haematuria traumatic | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Incisional hernia, obstructive | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Multiple drug overdose | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Periorbital haemorrhage | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Poisoning | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Postoperative thrombosis | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Weaning failure | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Acinetobacter test positive | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Angiogram | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Blood glucose fluctuation | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Catheterisation cardiac | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Coagulation time prolonged | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Electrocardiogram qt prolonged | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Electrocardiogram st segment elevation | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Occult blood | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA (14.1) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diabetic foot | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Shock hypoglycaemic | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Osteochondritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Benign laryngeal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Benign renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Benign small intestinal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Phaeochromocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Autonomic neuropathy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Basal ganglia haemorrhage | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Brain stem stroke | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Carotid arteriosclerosis | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Carotid artery aneurysm | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Carotid sinus syndrome | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cerebral hypoperfusion | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cervical root pain | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cluster headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Iiird nerve paresis | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Occipital neuralgia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumocephalus | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Post-traumatic epilepsy | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Radiculitis lumbosacral | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Spinal cord herniation | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Spinal cord infarction | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Viith nerve paralysis | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Psychosomatic disease | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Psychotic disorder due to a general medical condition | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bladder outlet obstruction | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Mesangioproliferative glomerulonephritis | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary tract inflammation | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Breast haematoma | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pelvic haematoma | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sexual dysfunction | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Alveolitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nocturnal dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Occupational asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Tonsillar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Tracheomalacia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dry gangrene | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Activities of daily living impaired | Social circumstances | MedDRA (14.1) | Systematic Assessment |
| |
| Elderly | Social circumstances | MedDRA (14.1) | Systematic Assessment |
| |
| Angioplasty | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Arterial repair | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac pacemaker battery replacement | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Coronary artery bypass | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Coronary revascularisation | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Hernia repair | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Implantable defibrillator replacement | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Knee operation | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Medical device implantation | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Percutaneous coronary intervention | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Rehabilitation therapy | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Umbilical hernia repair | Surgical and medical procedures | MedDRA (14.1) | Systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arterial disorder | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arterial insufficiency | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bleeding varicose vein | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diabetic vascular disorder | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Distributive shock | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Iliac artery thrombosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Temporal arteritis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Varicophlebitis | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Varicose ulceration | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010879 | Piperazines |
Not provided
Not provided
| Male |
|
| African |
|
| Hispanic |
|
| Asian |
|
| Other |
|
| Unknown |
|
| Philippines |
|
| Taiwan |
|
| Slovakia |
|
| Greece |
|
| Costa Rica |
|
| Thailand |
|
| Ukraine |
|
| Chile |
|
| Italy |
|
| India |
|
| France |
|
| Denmark |
|
| Korea, Republic of |
|
| Panama |
|
| Turkey |
|
| Czech Republic |
|
| Mexico |
|
| Canada |
|
| Brazil |
|
| Romania |
|
| Croatia |
|
| Sweden |
|
| United States |
|
| Serbia |
|
| Spain |
|
| Ireland |
|
| Israel |
|
| Russian Federation |
|
| Colombia |
|
| Switzerland |
|
| Malaysia |
|
| Peru |
|
| Australia |
|
| South Africa |
|
| Netherlands |
|
| Tunisia |
|
| China |
|
| Finland |
|
| Lithuania |
|
| Austria |
|
| Malta |
|
| United Kingdom |
|
| Egypt |
|
| Hungary |
|
| Argentina |
|
| Poland |
|
| Belgium |
|
| Singapore |
|
| Bulgaria |
|
| Germany |
|
| New Zealand |
|
| No |
|
| Unknown |
|
| No |
|
| Unknown |
|
| No |
|
| Unknown |
|
| Non-ST-segment Elevation Myocardial Infarction |
|
| Unknown/Did not meet criteria |
|
| Log Rank |
| 0.731 |
Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization. |
| Hazard Ratio (HR) |
| 1.029 |
| 2-Sided |
| 95 |
| 0.865 |
| 1.225 |
HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects. |
| No |
| Superiority or Other |
| OG002 |
| Clopidogrel: <75 Years of Age |
Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
| OG003 | Clopidogrel: 75 Years of Age or Older | Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
|
|
|
| OG002 | Clopidogrel: <75 Years of Age | Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
| OG003 | Clopidogrel: 75 Years of Age or Older | Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
|
|
|
| OG002 | Clopidogrel: <75 Years of Age | Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
| OG003 | Clopidogrel: 75 Years of Age or Older | Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
|
|
|
| OG002 | Clopidogrel: <75 Years of Age | Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
| OG003 | Clopidogrel: 75 Years of Age or Older | Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
|
|
|
| OG002 | Clopidogrel: <75 Years of Age | Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
| OG003 | Clopidogrel: 75 Years of Age or Older | Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
|
|
|
| OG002 | Clopidogrel: <75 Years of Age | Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
| OG003 | Clopidogrel: 75 Years of Age or Older | Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
|
|
|
| Prasugrel: 75 Years of Age or Older |
Prasugrel and Low-dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Prasugrel: 30 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 5 mg orally, once daily as maintenance dose through end of study. |
| OG002 | Clopidogrel: <75 Years of Age | Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
| OG003 | Clopidogrel: 75 Years of Age or Older | Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
|
|
| OG001 | Clopidogrel | Clopidogrel and Low-Dose Commercially-available Aspirin in participants. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
|
|
|
| OG002 | Clopidogrel: <75 Years of Age | Clopidogrel and Low-Dose Commercially-available Aspirin in participants less than (<) 75 years of age. Commercially-available Aspirin : Low-dose aspirin, oral, as prescribed by physician through end of study Clopidogrel : 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study |
| OG003 | Clopidogrel: 75 Years of Age or Older | Clopidogrel and Low-Dose Commercially-available Aspirin in participants 75 years of age or older. Commercially-available Aspirin: Low-dose aspirin, oral, as prescribed by physician through end of study. Clopidogrel: 300 milligram (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study. |
|
|