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| ID | Type | Description | Link |
|---|---|---|---|
| 11960 | Other Identifier | DAIDS-ES Registry Number | |
| 1U01HL123339-01 | U.S. NIH Grant/Contract | View source | |
| 1U01HL123336-01 | U.S. NIH Grant/Contract | View source | |
| EU5332 | Other Identifier | Massachusetts General Hospital |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Kowa Pharmaceuticals America, Inc. | INDUSTRY |
| Gilead Sciences | INDUSTRY |
| Massachusetts General Hospital |
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People with HIV are at risk for cardiovascular disease (CVD). This study evaluated the use of pitavastatin to reduce the risk of CVD in adults with HIV on antiretroviral therapy (ART).
The REPRIEVE trial consisted of two parallel identical protocols:
There are few strategies to prevent CVD in people with HIV (PWH), even though they are at high risk for developing CVD. Statin medications are used to lower cholesterol and may be effective at reducing the risk of CVD in PWH. The purpose of this study was to evaluate the use of pitavastatin to reduce the risk of CVD in PWH on ART.
This study enrolled PWH who were on any ART regimen (ART was not provided by the study) for at least 6 months before study entry and were at low to moderate risk of CVD using the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guideline thresholds for recommended statin initiation.
Participants were randomly assigned to receive 4 mg of pitavastatin or placebo once a day for their entire study duration. Pitavastatin or placebo could be discontinued and clinically indicated statin therapy initiated at the discretion of the site investigator or the participant's care provider, with the intention of following the participant according to the intention-to-treat trial design. Study visits occurred at study entry and Months 1 and 4. Starting at Month 4, study visits occurred every 4 months for the rest of the study. Depending on when participants enrolled, they were in the study for a total of 4 to 8 years. Study visits included medical and medication history reviews, physical examinations, blood collections, assessments and questionnaires, urine collections (for some participants), and an electrocardiogram (ECG) (at study entry only).
Participants at US sites had the option of enrolling in a substudy (Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers: Mechanistic Substudy of REPRIEVE [A5333s]). The substudy evaluated the effect of pitavastatin on the progression of non-calcified coronary atherosclerotic plaque (NCP) and inflammatory biomarkers in PWH. Participants in the substudy attended study visits at study entry and Months 4 and 24. The visits included questionnaires and assessments, a blood collection, and a coronary computed tomography angiography (CCTA). The Mechanistic Substudy closed to accrual on February 6, 2018, when its accrual target of 800 participants had been reached. Sites that enrolled participants into the Mechanistic Substudy are indicated with asterisk (*) at the end of the institution names in the Contacts and Locations section.
Participants enrolled in REPRIEVE from select study sites, including international sites, through December, 2017, were included in the REPRIEVE Kidney Function Objectives Cohort to evaluate the effects of pitavastatin on parameters of kidney function in the setting of HIV. These objectives include evaluating high risk groups and mechanisms driving kidney function decline in the setting of HIV.
Women and men enrolled in REPRIEVE after February, 2016 were included in an observational cohort (REPRIEVE Women's Objectives Cohort) facilitating assessment of sex-specific mechanisms of CVD risk and risk reduction among PWH. This effort also included an evidence-based recruitment campaign to enhance women's participation in REPRIEVE.
In response to the SARS-CoV-2 pandemic, a supplemental objective was added in 2020. To better understand how COVID-19 affects PWH and if pitavastatin may reduce the risk of serious COVID-19 disease, we evaluated interrelated but independent key topics including epidemiology, host factors, and protective strategies. Starting from April 2020, COVID-19 assessment was completed at each study visit, and blood was collected for COVID-19 biomarkers.
The data and safety monitoring board (DSMB) recommended stopping the trial for efficacy at the second planned review on March 30, 2023, and concluded that no unexpected safety concerns had been reported. Following the DSMB action, participants were asked to return for the final study visit. All final visits were completed by August 21, 2023. We here present the results based on the final trial database, including the full follow-up out to closeout visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin | Experimental | Participants received pitavastatin once a day for the entire time they were in study follow-up. |
|
| Placebo | Placebo Comparator | Participants received placebo for pitavastatin once a day for the entire time they were in study follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | One tablet (4 mg) taken once daily, orally with or without food |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Major Adverse Cardiovascular Event (MACE) | MACE is a composite of cardiovascular (CV) death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack (TIA), peripheral arterial ischemia, coronary, carotid or peripheral arterial revascularization, or death from an undetermined cause. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Non-CV deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Cardiac Ischemia or Myocardial Infarction | Cardiac ischemia or myocardial infarction component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of MACE by Sex | Subgroup analysis of the primary composite MACE outcome measure (as described above) by sex. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The Cox proportional hazards models described for the primary outcome above were expanded to include sex and interaction of sex and treatment, to evaluate modification of statin effect. |
Inclusion Criteria:
Individual with HIV-1
Combination antiretroviral therapy (ART) for at least 180 days prior to study entry
CD4+ cell count greater than 100 cells/mm^3
Acceptable screening laboratories including:
Fasting low-density lipoprotein (LDL) cholesterol as follows:
Fasting triglycerides less than 500 mg/dL
Hemoglobin greater than or equal to 8 g/dL for female participants and greater than or equal to 9 g/dL for male participants
Glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m^2 or creatinine clearance (CrCl) greater than or equal to 60 mL/min
Alanine aminotransferase (ALT) less than or equal to 2.5 x the upper limit of normal (ULN)
For persons with known chronic active hepatitis B or C, calculated fibrosis 4 score (FIB-4) must have been less than or equal to 3.25
Ability and willingness of participant or legal representative to provide written informed consent
Exclusion Criteria:
Clinical ASCVD, as defined by 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines, including a previous diagnosis of any of the following:
Current diabetes mellitus with LDL greater than or equal to 70 mg/dL
10-year ASCVD risk score estimated by Pooled Cohort Equations greater than 15%
Active cancer within 12 months prior to study entry, except successfully treated non-melanomatous skin cancer and Kaposi sarcoma without visceral organ involvement
Known decompensated cirrhosis
History of myositis or myopathy with active disease in the 180 days prior to study entry
Known untreated symptomatic thyroid disease
History of allergy or severe adverse reaction to statins
Use of specific immunosuppressants or immunomodulatory agents including but not limited to tacrolimus, sirolimus, rapamycin, mycophenolate, cyclosporine, tumor necrosis factor (TNF)-alpha blockers or antagonists, azathioprine, interferon, growth factors, or intravenous immunoglobulin (IVIG) in the 30 days prior to study entry.
Current use of erythromycin, colchicine, or rifampin
Use of any statin drugs, gemfibrozil, or PCSK9 inhibitors in the 90 days prior to study entry
Current use of an investigational new drug that would be contraindicated
Serious illness or trauma requiring systemic treatment or hospitalization in the 30 days prior to study entry
Current pregnancy or breastfeeding
Alcohol or drug use that, in the opinion of the site investigator, would interfere with completion of study procedures
Other medical, psychiatric, or psychological condition that, in the opinion of the site investigator, would interfere with completion of study procedures and or adherence to study drug
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| Name | Affiliation | Role |
|---|---|---|
| Steven Grinspoon, MD | Harvard Medical School (HMS and HSDM) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama CRS* | Birmingham | Alabama | 35294 | United States | ||
| University of Arizona CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24239921 | Background | Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB Sr, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PWF. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2935-2959. doi: 10.1016/j.jacc.2013.11.005. Epub 2013 Nov 12. No abstract available. | |
| 28277924 |
| Label | URL |
|---|---|
| REPRIEVE Trial Website | View source |
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4 inadvertent duplicate enrollments of the same person were excluded. The total enrollment number of 7769 represents unique participants enrolled.
Participants were enrolled from March 26, 2015 to July 31, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin | Participants received pitavastatin once a day for the entire time they were in study follow-up. Pitavastatin: One tablet (4 mg) taken once daily, orally with or without food |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form: English | May 16, 2022 |
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| OTHER |
| NEAT ID Foundation | OTHER |
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| Placebo |
| Drug |
One tablet taken once daily, orally with or without food |
|
| From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Cerebrovascular Event (Stroke or TIA) | Cerebrovascular event (stroke or TIA) component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Peripheral Arterial Ischemia | Peripheral arterial ischemia component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Death From CV Causes | CV death component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Non-CV deaths and deaths from undetermined causes were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Death From CV or Undetermined Causes | CV or undetermined death component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Non-CV deaths were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Cardiac Catheterization or Revascularization | Cardiac cardiac catheterization or revascularization component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Carotid or Cerebrovascular Revascularization | Carotid or cerebrovascular revascularization component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Peripheral Arterial Revascularization | Peripheral arterial revascularization component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of MACE or Death | A composite outcome including MACE and death from any cause. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Death (All-cause) | Death from any cause. The incidence rates were estimated based on time to event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Non-CV Clinical Diagnoses | A composite of non-CV clinical diagnoses including: non-AIDS-defining cancers (excluding basal cell and squamous cell carcinomas of the skin), AIDS-defining events (based on Centers for Disease Control and Prevention [CDC] 2014 classification), end-stage renal disease, and end-stage liver disease. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Non-AIDS-defining Cancer | Non-AIDS-defining cancer (excluding basal cell and squamous cell carcinomas of the skin) component of the composite non-CV clinical diagnoses outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of AIDS-defining Event | AIDS-defining event component of the composite non-CV clinical diagnoses outcome. Events were captured based on the Centers for Disease Control and Prevention [CDC] 2014 classification. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of End-Stage Renal Disease | End-stage renal disease (defined as initiation of dialysis or renal transplantation) component of the composite non-CV clinical diagnoses outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of End-Stage Liver Disease | End-stage liver disease (defined as cirrhosis or hepatic decompensation requiring hospitalization) component of the composite non-CV clinical diagnoses outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Non-fatal Serious Adverse Event | Safety analysis outcome measure of non-fatal serious adverse event was defined by International Conference on Harmonisation (ICH) criteria. Fatal events were excluded as deaths were a secondary efficacy outcome (see outcome measure: incidence rate of death (all-cause)). The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo), adjusted for screening CD4 and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Diabetes | Safety analysis outcome measure of diabetes was defined as new diagnosis of diabetes with initiation of anti-diabetic agent. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo), adjusted for screening CD4 and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Myalgia, Muscle Weakness or Myopathy | Safety analysis outcome measure of myalgia, muscle weakness or myopathy which were grade 3 or higher or treatment-limiting. Grade 3 or higher includes grade 3 and 4 events, where grade 3 refers to severe and grade 4 to life-threatening according to DAIDS AE Grading Table (version 2.1). The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo), adjusted for screening CD4 and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Rhabdomyolysis | Safety analysis outcome measure of rhabdomyolysis which was grade 3 or higher or treatment-limiting. Grade 3 or higher includes grade 3 and 4 events, where grade 3 refers to severe and grade 4 to life-threatening, according to DAIDS AE Grading Table (version 2.1). The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo). Due to small number of events, there was no adjustment for screening CD4 and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Grade 3 or Higher ALT | Safety analysis outcome measure of Grade 3 or higher alanine transaminase (ALT). Grade 3 or higher includes grade 3 and 4 events, where grade 3 refers to severe and grade 4 to life-threatening, according to DAIDS AE Grading Table (version 2.1). The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo). Due to small number of events, there was no adjustment for screening CD4 and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of Adverse Event (AE) | Safety analysis outcome measure of any AE. AE collection included events of grade ≥3, those that were serious (defined by International Conference on Harmonisation (ICH) criteria) or treatment-limiting, and targeted diagnosis of diabetes. Grade ≥3 includes events that were grade 3 (serious) or grade 4 (life-threatening) per DAIDS AE Grading Table (version 2.1). Fatal events were excluded as deaths were a secondary efficacy outcome (see outcome measure: incidence rate of death (all-cause)). The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo), adjusted for screening CD4 and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Fasting Low-density Lipoprotein Cholesterol (LDL-C) | LDL-C level was derived as LDL-C calculated according to the Friedewald formula at triglycerides ≤400 mg/dL, and direct LDL-C at triglycerides >400 to <500 mg/dL. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | At entry and months 12, 24, 36, 48, 60, 72, 84. Participants' follow-up time on study varied, depending on their time of enrollment. |
| Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Non-HDL cholesterol levels were calculated as total cholesterol minus HDL cholesterol. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | At entry and months 12, 24, 36, 48, 60, 72, 84. Participants' follow-up time on study varied, depending on their time of enrollment. |
| Incidence Rate of Serious COVID-19 | Serious COVID-19 was defined as COVID-19 that resulted in hospitalization or death or was life-threatening as per the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline E2A definition. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo), adjusted for GBD region to account for regional differences. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From January 1, 2020 through end of study; the median follow-up time was 3.3 years. |
| Incidence Rate of COVID-19 | COVID-19 was defined as COVID-19 clinical diagnosis or positive test result (SARS-CoV-2 PCR or rapid antigen tests). The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios (prescribed pitavastatin compared to placebo) from Poisson regression models, adjusted for GBD region to account for regional differences. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | From January 1, 2020 through end of study; the median follow-up time was 3.3 years. |
| For Mechanistic Substudy: Change in Non-Calcified Plaque (NCP) Volume From Baseline to Year 2 | NCP was defined as plaque voxels with attenuation of <350. Change in NCP is expressed as absolute change from baseline (calculated as NCP volume at 2 years minus NCP volume at entry), based on quantitative read of the CT scan, whenever available. Participants without a quantitative read and no evidence of NCP based on the corresponding qualitative read were assigned a value of zero for the change. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Entry and Year 2. |
| For Mechanistic Substudy: Number of Participants With Progression of NCP From Baseline to Year 2 | Progression at Year 2 was defined as any progression/increase in NCP volume in participants with evidence of NCP at entry, or incident NCP in participants without evidence of NCP at entry. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Entry and year 2. |
| For Mechanistic Substudy: Change in Total Plaque Volume From Baseline to Year 2 | Total plaque includes all plaque voxels (noncalcified + calcified). Change in total plaque volume is expressed as absolute change from baseline (calculated as volume at 2 years minus volume at entry). Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Entry and year 2. |
| For Mechanistic Substudy: LpPLA2 Level | Level of inflammatory biomarker lipoprotein-associated phospholipase A2 (LpPLA2). Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Entry and month 24. |
| For Mechanistic Substudy: Change in LpPLA2 From Baseline | Change in inflammatory biomarker LpPLA2 from baseline calculated as value at month 24 minus value at entry. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Entry and month 24. |
| For Mechanistic Substudy: HsCRP Level | Level of inflammatory marker high-sensitivity C-reactive protein (HsCRP). Censored values below or above the assay limit were imputed. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Entry and month 24. |
| For Mechanistic Substudy: Change in HsCRP From Baseline | Change in inflammatory biomarker hsCRP from baseline calculated as value at month 24 minus value at entry. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Entry and month 24. |
| For Mechanistic Substudy: Soluble CD163 Level | Level of immune biomarker soluble CD163. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Entry and month 24. |
| For Mechanistic Substudy: Change in Soluble CD163 From Baseline | Change in immune biomarker soluble CD163 from baseline calculated as value at month 24 minus value at entry. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Entry and month 24. |
| From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Incidence Rate of MACE by Race | Subgroup analysis of the primary composite MACE outcome measure (as described above) by race. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The Cox proportional hazards models described for the primary outcome above were expanded to include race and interaction of race and treatment, to evaluate modification of statin effect. | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| Tucson |
| Arizona |
| 85724 |
| United States |
| University of Southern California CRS* | Los Angeles | California | 90033-1079 | United States |
| UCLA CARE Center CRS* | Los Angeles | California | 90035 | United States |
| Mills Clinical Research CRS | Los Angeles | California | 90069 | United States |
| VA West Los Angeles Medical Center CRS | Los Angeles | California | 90073 | United States |
| Los Angeles LGBT Center CRS | Los Angeles | California | 90232 | United States |
| Eisenhower Health Center at Rimrock CRS | Palm Springs | California | 92264 | United States |
| Stanford AIDS Clinical Trials Unit CRS | Palo Alto | California | 94304-5350 | United States |
| UCSD Antiviral Research Center CRS* | San Diego | California | 92103 | United States |
| Ucsf Hiv/Aids Crs* | San Francisco | California | 94110 | United States |
| Harbor-UCLA CRS* | Torrance | California | 90502 | United States |
| University of Colorado Hospital CRS* | Aurora | Colorado | 80045 | United States |
| Denver Public Health CRS | Denver | Colorado | 80204 | United States |
| Yale University CRS | New Haven | Connecticut | 06510 | United States |
| VA Connecticut Healthcare System CRS | West Haven | Connecticut | 06516 | United States |
| Whitman-Walker Health CRS | Washington D.C. | District of Columbia | 20005 | United States |
| Georgetown University CRS (GU CRS) | Washington D.C. | District of Columbia | 20007 | United States |
| Capital Medical Associates, PC CRS | Washington D.C. | District of Columbia | 20036 | United States |
| Infectious Diseases Clinic, Washington DC Veterans Affairs Medical Center CRS | Washington D.C. | District of Columbia | 20422 | United States |
| Malcom Randall VA Medical Center CRS | Gainesville | Florida | 32610 | United States |
| AHF-The Kinder Medical Group CRS | Miami | Florida | 33133 | United States |
| The University of Miami AIDS Clinical Research Unit (ACRU) CRS | Miami | Florida | 33136 | United States |
| University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS | Miami | Florida | 33136 | United States |
| AHF - South Beach CRS | Miami | Florida | 33140 | United States |
| Orlando Immunology Center CRS | Orlando | Florida | 32803 | United States |
| Community AIDS Network/Comprehensive Care Clinic CRS | Sarasota | Florida | 34237 | United States |
| Florida Department of Health - Hillsborough County | Tampa | Florida | 33602 | United States |
| AIDS Research and Treatment Center of the Treasure Coast CRS | Vero Beach | Florida | 32960 | United States |
| The Ponce de Leon Center CRS | Atlanta | Georgia | 30308-2012 | United States |
| Augusta University Research Institute, Inc. CRS | Augusta | Georgia | 30912 | United States |
| Northwestern University CRS* | Chicago | Illinois | 60611 | United States |
| Rush University CRS* | Chicago | Illinois | 60612 | United States |
| UIC Project WISH CRS | Chicago | Illinois | 60612 | United States |
| Indiana University Infectious Diseases Research CRS | Indianapolis | Indiana | 46202 | United States |
| Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS | Iowa City | Iowa | 52242 | United States |
| Bluegrass Care Clinic/University of Kentucky Research Foundation CRS | Lexington | Kentucky | 40536 | United States |
| 550 Clinic -University of Louisville CRS | Louisville | Kentucky | 40202 | United States |
| Tulane - Louisiana Community AIDS Research Program (T-LaCARP) CRS | New Orleans | Louisiana | 70112 | United States |
| Johns Hopkins University CRS* | Baltimore | Maryland | 21205 | United States |
| Tufts Medical Center CRS | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital CRS (MGH CRS)* | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS* | Boston | Massachusetts | 02115 | United States |
| Boston Medical Center CRS | Boston | Massachusetts | 02118 | United States |
| Baystate Infectious Diseases Clinical Research CRS | Springfield | Massachusetts | 01199 | United States |
| Henry Ford Hosp. CRS | Detroit | Michigan | 48202 | United States |
| St. John Newland Medical Associates CRS | Southfield | Michigan | 48075 | United States |
| Abbott Northwestern Hospital CRS | Minneapolis | Minnesota | 55407 | United States |
| University of Mississippi Medical Center CRS | Jackson | Mississippi | 39213 | United States |
| Washington University Therapeutics (WT) CRS* | St Louis | Missouri | 63110-1010 | United States |
| Specialty Care Center CRS | Omaha | Nebraska | 68106 | United States |
| Cooper Univ. Hosp. CRS | Camden | New Jersey | 08103 | United States |
| New Jersey Medical School Clinical Research Center CRS* | Newark | New Jersey | 07103 | United States |
| Mount Sinai Beth Israel CRS* | New York | New York | 10003 | United States |
| VA New York Harbor Healthcare System (NYHHS), NY Campus CRS | New York | New York | 10010 | United States |
| Weill Cornell Chelsea CRS* | New York | New York | 10010 | United States |
| Mount Sinai Downtown CRS* | New York | New York | 10011 | United States |
| Mount Sinai West Samuels CRS* | New York | New York | 10019 | United States |
| Mount Sinai St. Luke's Morningside CRS* | New York | New York | 10025 | United States |
| Infectious Disease Clinical and Translational Research Center (CTRC) CRS | New York | New York | 10029 | United States |
| Columbia P&S CRS* | New York | New York | 10032-3732 | United States |
| Weill Cornell Uptown CRS* | New York | New York | 10065 | United States |
| University of Rochester Adult HIV Therapeutic Strategies Network CRS* | Rochester | New York | 14642 | United States |
| James J Peters VA Medical Center CRS | The Bronx | New York | 10468 | United States |
| Chapel Hill CRS* | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center CRS | Durham | North Carolina | 27710 | United States |
| Greensboro CRS* | Greensboro | North Carolina | 27401 | United States |
| Wake Forest Baptist Medical Center CRS | Winston-Salem | North Carolina | 27157 | United States |
| Cincinnati Clinical Research Site* | Cincinnati | Ohio | 45219 | United States |
| Case Clinical Research Site* | Cleveland | Ohio | 44106 | United States |
| Ohio State University CRS* | Columbus | Ohio | 43210 | United States |
| University of Toledo Medical Center CRS | Toledo | Ohio | 43614 | United States |
| Oklahoma State University Center for Health Sciences CRS | Tulsa | Oklahoma | 74127 | United States |
| Division of Infectious Diseases Clinical Research Center- Drexel University CRS | Philadelphia | Pennsylvania | 19102 | United States |
| Penn Therapeutics, CRS* | Philadelphia | Pennsylvania | 19104 | United States |
| Center of Translational AIDS Research, Lewis Katz School of Medicine at Temple University CRS | Philadelphia | Pennsylvania | 19140 | United States |
| Positive Health Clinic CRS | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh CRS* | Pittsburgh | Pennsylvania | 15213 | United States |
| The Miriam Hospital Clinical Research Site (TMH CRS) CRS* | Providence | Rhode Island | 02906 | United States |
| Medical University of South Carolina: Division of Infectious Diseases CRS | Charleston | South Carolina | 29425 | United States |
| Prisma Health CRS | Columbia | South Carolina | 29209 | United States |
| Vanderbilt Therapeutics (VT) CRS* | Nashville | Tennessee | 37204 | United States |
| Trinity Health and Wellness Center CRS | Dallas | Texas | 75208 | United States |
| Dallas VA Medical Center CRS | Dallas | Texas | 75216 | United States |
| UT Southwestern HIV/ID Clinical Trials Unit CRS | Dallas | Texas | 75235-9173 | United States |
| Houston AIDS Research Team CRS* | Houston | Texas | 77030 | United States |
| Michael E. DeBakey VAMC REPRIEVE CRS | Houston | Texas | 77030 | United States |
| Inova Heart and Vascular Institute CRS | Falls Church | Virginia | 22042 | United States |
| Virginia Commonwealth University CRS | Richmond | Virginia | 23298 | United States |
| University of Washington AIDS CRS* | Seattle | Washington | 98104-9929 | United States |
| Medical College of Wisconsin, Inc. CRS | Milwaukee | Wisconsin | 53226 | United States |
| Gaborone CRS | Gaborone | South-East District | Botswana |
| Tropical Medicine Foundation Dr. Heitor Vieira Dourado CRS | Manaus | Amazonas | 69040000 | Brazil |
| School of Medicine, Federal University of Minas Gerais CRS | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| HGNI HIV Family Care Clinic - HHFCC CRS | Nova Iguaçu | Rio de Janeiro | 26030-380 | Brazil |
| Hospital Nossa Senhora da Conceicao CRS | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Centro de Referencia e Treinamento DST/AIDS CRS | São Paulo | São Paulo | 04121-000 | Brazil |
| Projeto Praça Onze Pesquisa em Saúde CRS | Rio de Janeiro | 20020-000 | Brazil |
| Hospital Federal dos Servidores do Estado CRS | Rio de Janeiro | 20221-903 | Brazil |
| Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS | Rio de Janeiro | 21040-360 | Brazil |
| Instituto de Infectologia Emilio Ribas CRS | São Paulo | 01246-900 | Brazil |
| Centro de Pesquisas ClÃnicas IC-HCFMUSP CRS | São Paulo | 05403-010 | Brazil |
| Vancouver ID Research & Care Centre Society CRS | Vancouver | British Columbia | V6Z 2C7 | Canada |
| Hamilton Health Sciences - Special Immunology Services Clinic CRS | Hamilton | Ontario | L8S 1A4 | Canada |
| Maple Leaf Research CRS | Toronto | Ontario | M5G 1K2 | Canada |
| Toronto General Hospital CRS | Toronto | Ontario | M5G 2N2 | Canada |
| Chronic Viral Illness Service CRS | Montreal | Quebec | H4A 3J1 | Canada |
| Centre hospitalier de l'Université Laval CRS | Québec | Quebec | G1V 4G2 | Canada |
| GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS | Port-au-Prince | HT-6110 | Haiti |
| Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS | Port-au-Prince | HT-6110 | Haiti |
| Byramjee Jeejeebhoy Medical College (BJMC) CRS | Pune | Maharashtra | 411001 | India |
| Chennai Antiviral Research and Treatment (CART) CRS | Chennai | Tamil Nadu | 600113 | India |
| Barranco CRS | Lima | 15063 | Peru |
| San Miguel CRS | Lima | 32 - 15088 | Peru |
| Puerto Rico AIDS Clinical Trials Unit CRS* | San Juan | PR | 00935 | Puerto Rico |
| Soweto ACTG CRS | Johannesburg | Gauteng | 1862 | South Africa |
| Wits Helen Joseph Hospital CRS (Wits HJH CRS) | Johannesburg | Gauteng | 2092 | South Africa |
| Durban International Clinical Research Site CRS | Durban | KwaZulu-Natal | 4052 | South Africa |
| University of Cape Town Lung Institute (UCTLI) CRS | Cape Town | Western Cape | 7700 | South Africa |
| Famcru Crs | Tygerberg | Western Cape | 7505 | South Africa |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Germans Trias i Pujol | Badalona | 080916 | Spain |
| Hospital Universitario Valle d'Hebron | Barcelona | 08003 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Universitario de Basurto de Basurto | Bilbao | 48013 | Spain |
| Hospital General Universitario De Elche | Elche | 03203 | Spain |
| Hospital Gregorio Universitario Maranon | Madrid | 28007 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Thai Red Cross AIDS Research Centre (TRC-ARC) CRS | Bangkok | 10330 | Thailand |
| Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS | Chiang Mai | 50200 | Thailand |
| Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site | Kampala | Uganda |
| Milton Park CRS | Harare | Zimbabwe |
| Result |
| Zanni MV, Fitch K, Rivard C, Sanchez L, Douglas PS, Grinspoon S, Smeaton L, Currier JS, Looby SE. Follow YOUR Heart: development of an evidence-based campaign empowering older women with HIV to participate in a large-scale cardiovascular disease prevention trial. HIV Clin Trials. 2017 Mar;18(2):83-91. doi: 10.1080/15284336.2017.1297551. |
| 30928825 | Result | Grinspoon SK, Fitch KV, Overton ET, Fichtenbaum CJ, Zanni MV, Aberg JA, Malvestutto C, Lu MT, Currier JS, Sponseller CA, Waclawiw M, Alston-Smith B, Cooper-Arnold K, Klingman KL, Desvigne-Nickens P, Hoffmann U, Ribaudo HJ, Douglas PS; REPRIEVE Investigators. Rationale and design of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE). Am Heart J. 2019 Jun;212:23-35. doi: 10.1016/j.ahj.2018.12.016. Epub 2019 Mar 4. |
| 30928823 | Result | Hoffmann U, Lu MT, Olalere D, Adami EC, Osborne MT, Ivanov A, Aluru JS, Lee S, Arifovic N, Overton ET, Fichtenbaum CJ, Aberg JA, Alston-Smith B, Klingman KL, Waclawiw M, Burdo TH, Williams KC, Zanni MV, Desvigne-Nickens P, Cooper-Arnold K, Fitch KV, Ribaudo H, Douglas PS, Grinspoon SK; REPRIEVE Investigators. Rationale and design of the Mechanistic Substudy of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE): Effects of pitavastatin on coronary artery disease and inflammatory biomarkers. Am Heart J. 2019 Jun;212:1-12. doi: 10.1016/j.ahj.2019.02.011. Epub 2019 Mar 4. |
| 32645161 | Result | Grinspoon SK, Douglas PS, Hoffmann U, Ribaudo HJ. Leveraging a Landmark Trial of Primary Cardiovascular Disease Prevention in Human Immunodeficiency Virus: Introduction From the REPRIEVE Coprincipal Investigators. J Infect Dis. 2020 Jul 9;222(Suppl 1):S1-S7. doi: 10.1093/infdis/jiaa098. |
| 32160827 | Result | Fitch KV, Kileel EM, Looby SE, Zanni MV, Sanchez LR, Fichtenbaum CJ, Overton ET, Malvestutto C, Aberg JA, Klingman KL, Alston-Smith B, Lavelle J, Rancourt A, Badal-Faesen S, Cardoso SW, Avihingsanon A, Patil S, Sponseller CA, Melbourne K, Ribaudo HJ, Cooper-Arnold K, Desvigne-Nickens P, Hoffmann U, Douglas PS, Grinspoon SK; REPRIEVE Investigators. Successful recruitment of a multi-site international randomized placebo-controlled trial in people with HIV with attention to diversity of race and ethnicity: critical role of central coordination. HIV Res Clin Pract. 2020 Feb;21(1):11-23. doi: 10.1080/25787489.2020.1733794. Epub 2020 Mar 11. |
| 32645164 | Result | Overton ET, Kantor A, Fitch KV, Muntner P, Supparatpinyo K, Mosepele M, Mohapi L, Cardoso SW, Patil S, de Lacerda MVG, McComsey G, Aberg JA, Douglas PS, Grinspoon SK, Ribaudo H, Wyatt CM. An Evaluation of Baseline Kidney Function in the REPRIEVE Trial of Pitavastatin in Human Immunodeficiency Virus. J Infect Dis. 2020 Jul 9;222(Suppl 1):S41-S51. doi: 10.1093/infdis/jiaa222. |
| 32645162 | Result | Fichtenbaum CJ, Ribaudo HJ, Leon-Cruz J, Overton ET, Zanni MV, Malvestutto CD, Aberg JA, Kileel EM, Fitch KV, Van Schalkwyk M, Kumarasamy N, Martinez E, Santos BR, Joseph Y, Lo J, Siminski S, Melbourne K, Sponseller CA, Desvigne-Nickens P, Bloomfield GS, Currier JS, Hoffmann U, Douglas PS, Grinspoon SK; REPRIEVE Investigators. Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial. J Infect Dis. 2020 Jul 9;222(Suppl 1):S8-S19. doi: 10.1093/infdis/jiaa259. |
| 32645160 | Result | Smeaton LM, Kileel EM, Grinsztejn B, Gardner EM, Starr K, Murry ML, Desvigne-Nickens P, Alston-Smith B, Waclawiw MA, Cooper-Arnold K, Madruga JV, Sangle S, Fitch KV, Zanni MV, Douglas PS, Ribaudo HJ, Grinspoon SK, Klingman KL. Characteristics of REPRIEVE Trial Participants Identifying Across the Transgender Spectrum. J Infect Dis. 2020 Jul 9;222(Suppl 1):S31-S40. doi: 10.1093/infdis/jiaa213. |
| 32645159 | Result | Zanni MV, Currier JS, Kantor A, Smeaton L, Rivard C, Taron J, Burdo TH, Badal-Faesen S, Lalloo UG, Pinto JA, Samaneka W, Valencia J, Klingman K, Allston-Smith B, Cooper-Arnold K, Desvigne-Nickens P, Lu MT, Fitch KV, Hoffman U, Grinspoon SK, Douglas PS, Looby SE. Correlates and Timing of Reproductive Aging Transitions in a Global Cohort of Midlife Women With Human Immunodeficiency Virus: Insights From the REPRIEVE Trial. J Infect Dis. 2020 Jul 9;222(Suppl 1):S20-S30. doi: 10.1093/infdis/jiaa214. |
| 32645158 | Result | Neilan TG, Nguyen KL, Zaha VG, Chew KW, Morrison L, Ntusi NAB, Toribio M, Awadalla M, Drobni ZD, Nelson MD, Burdo TH, Van Schalkwyk M, Sax PE, Skiest DJ, Tashima K, Landovitz RJ, Daar E, Wurcel AG, Robbins GK, Bolan RK, Fitch KV, Currier JS, Bloomfield GS, Desvigne-Nickens P, Douglas PS, Hoffmann U, Grinspoon SK, Ribaudo H, Dawson R, Goetz MB, Jain MK, Warner A, Szczepaniak LS, Zanni MV. Myocardial Steatosis Among Antiretroviral Therapy-Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial. J Infect Dis. 2020 Jul 9;222(Suppl 1):S63-S69. doi: 10.1093/infdis/jiaa245. |
| 34134131 | Result | Douglas PS, Umbleja T, Bloomfield GS, Fichtenbaum CJ, Zanni MV, Overton ET, Fitch KV, Kileel EM, Aberg JA, Currier J, Sponseller CA, Melbourne K, Avihingsanon A, Bustorff F, Estrada V, Ruxrungtham K, Saumoy M, Navar AM, Hoffmann U, Ribaudo HJ, Grinspoon S. Cardiovascular Risk and Health Among People With Human Immunodeficiency Virus (HIV) Eligible for Primary Prevention: Insights From the REPRIEVE Trial. Clin Infect Dis. 2021 Dec 6;73(11):2009-2022. doi: 10.1093/cid/ciab552. |
| 34185068 | Result | Hoffmann U, Lu MT, Foldyna B, Zanni MV, Karady J, Taron J, Zhai BK, Burdo T, Fitch KV, Kileel EM, Williams K, Fichtenbaum CJ, Overton ET, Malvestutto C, Aberg J, Currier J, Sponseller CA, Melbourne K, Floris-Moore M, Van Dam C, Keefer MC, Koletar SL, Douglas PS, Ribaudo H, Mayrhofer T, Grinspoon SK; REPRIEVE trial. Assessment of Coronary Artery Disease With Computed Tomography Angiography and Inflammatory and Immune Activation Biomarkers Among Adults With HIV Eligible for Primary Cardiovascular Prevention. JAMA Netw Open. 2021 Jun 1;4(6):e2114923. doi: 10.1001/jamanetworkopen.2021.14923. |
| 34888395 | Result | Kileel EM, Lo J, Malvestutto C, Fitch KV, Zanni MV, Fichtenbaum CJ, Overton ET, Okeke NL, Kumar P, Joao E, Aberg JA, Martinez E, Currier JS, Douglas PS, Ribaudo HJ, Grinspoon SK. Assessment of Obesity and Cardiometabolic Status by Integrase Inhibitor Use in REPRIEVE: A Propensity-Weighted Analysis of a Multinational Primary Cardiovascular Prevention Cohort of People With Human Immunodeficiency Virus. Open Forum Infect Dis. 2021 Nov 20;8(12):ofab537. doi: 10.1093/ofid/ofab537. eCollection 2021 Dec. |
| 34794178 | Result | Fulda ES, Fitch KV, Overton ET, Zanni MV, Aberg JA, Currier JS, Lu MT, Malvestutto C, Fichtenbaum CJ, Martinez E, Umbleja T, Douglas PS, Ribaudo HJ, Grinspoon SK. COVID-19 Vaccination Rates in a Global HIV Cohort. J Infect Dis. 2022 Feb 15;225(4):603-607. doi: 10.1093/infdis/jiab575. |
| 35147583 | Result | Bloomfield GS, Weir IR, Ribaudo HJ, Fitch KV, Fichtenbaum CJ, Moran LE, Bedimo R, de Filippi C, Morse CG, Piccini J, Zanni MV, Lu MT, Hoffmann U, Grinspoon SK, Douglas PS. Prevalence and Correlates of Electrocardiographic Abnormalities in Adults With HIV: Insights From the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE). J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):349-359. doi: 10.1097/QAI.0000000000002877. |
| 35165682 | Result | Erlandson KM, Fitch KV, McCallum SA, Ribaudo HJ, Overton ET, Zanni MV, Bloomfield GS, Brown TT, Fichtenbaum CJ, Bares S, Aberg JA, Douglas PS, Fulda ES, Santana-Bagur JL, Castro JG, Moran LE, Mave V, Supparatpinyo K, Ponatshego PL, Schechter M, Grinspoon SK. Geographical Differences in the Self-Reported Functional Impairment of People With Human Immunodeficiency Virus (HIV) and Associations With Cardiometabolic Risk. Clin Infect Dis. 2022 Sep 30;75(7):1154-1163. doi: 10.1093/cid/ciac098. |
| 35235653 | Result | Looby SE, Kantor A, Burdo TH, Currier JS, Fichtenbaum CJ, Overton ET, Aberg JA, Malvestutto CD, Bloomfield GS, Erlandson KM, Cespedes M, Kallas EG, Masia M, Thornton AC, Smith MD, Flynn JM, Kileel EM, Fulda E, Fitch KV, Lu MT, Douglas PS, Grinspoon SK, Ribaudo HJ, Zanni MV. Factors Associated With Systemic Immune Activation Indices in a Global Primary Cardiovascular Disease Prevention Cohort of People With Human Immunodeficiency Virus on Antiretroviral Therapy. Clin Infect Dis. 2022 Oct 12;75(8):1324-1333. doi: 10.1093/cid/ciac166. |
| 35413022 | Result | Overton ET, Weir IR, Zanni MV, Fischinger S, MacArthur RD, Aberg JA, Fitch KV, Frank M, Albrecht H, Goodenough E, Rhame FS, Fichtenbaum CJ, Bloomfield GS, Malvestutto C, Supparatpinyo K, McCallum S, Douglas PS, Alter G, Ribaudo H, Grinspoon SK. Asymptomatic SARS-CoV-2 Infection Is Common Among ART-Treated People With HIV. J Acquir Immune Defic Syndr. 2022 Aug 1;90(4):377-381. doi: 10.1097/QAI.0000000000003000. |
| 35876637 | Result | Fitch KV, McCallum SA, Erlandson KM, Overton ET, Zanni MV, Fichtenbaum C, Aberg JA, Fulda ES, Kileel EM, Moran LE, Bloomfield GS, Novak RM, Perez-Frontera S, Abrams-Downey A, Pierone G Jr, Kumarasamy N, Ruxrungtham K, Mngqibisa R, Douglas PS, Ribaudo HJ, Grinspoon SK. Diet in a global cohort of adults with HIV at low-to-moderate traditional cardiovascular disease risk. AIDS. 2022 Nov 15;36(14):1997-2003. doi: 10.1097/QAD.0000000000003344. Epub 2022 Jul 27. |
| 35535576 | Result | Kolossvary M, deFilippi C, Lu MT, Zanni MV, Fulda ES, Foldyna B, Ribaudo H, Mayrhofer T, Collier AC, Bloomfield GS, Fichtenbaum C, Overton ET, Aberg JA, Currier J, Fitch KV, Douglas PS, Grinspoon SK. Proteomic Signature of Subclinical Coronary Artery Disease in People With HIV: Analysis of the REPRIEVE Mechanistic Substudy. J Infect Dis. 2022 Nov 11;226(10):1809-1822. doi: 10.1093/infdis/jiac196. |
| 36101518 | Result | Zanni MV, Foldyna B, McCallum S, Burdo TH, Looby SE, Fitch KV, Fulda ES, Autissier P, Bloomfield GS, Malvestutto CD, Fichtenbaum CJ, Overton ET, Aberg JA, Erlandson KM, Campbell TB, Ellsworth GB, Sheth AN, Taiwo B, Currier JS, Hoffmann U, Lu MT, Douglas PS, Ribaudo HJ, Grinspoon SK. Sex Differences in Subclinical Atherosclerosis and Systemic Immune Activation/Inflammation Among People With Human Immunodeficiency Virus in the United States. Clin Infect Dis. 2023 Jan 13;76(2):323-334. doi: 10.1093/cid/ciac767. |
| 35975297 | Result | Schnittman SR, Lu MT, Mayrhofer T, Burdo TH, Fitch KV, McCallum S, Fulda ES, Zanni MV, Foldyna B, Malvestutto C, Fichtenbaum CJ, Aberg JA, Bloomfield GS, Overton ET, Currier J, Tebas P, Sha BE, Ribaudo HJ, Flynn JM, Douglas PS, Erlandson KM, Grinspoon SK. Cytomegalovirus Immunoglobulin G (IgG) Titer and Coronary Artery Disease in People With Human Immunodeficiency Virus (HIV). Clin Infect Dis. 2023 Feb 8;76(3):e613-e621. doi: 10.1093/cid/ciac662. |
| 36525544 | Result | Douglas PS, McCallum S, Lu MT, Umbleja T, Fitch KV, Foldyna B, Zanni MV, Fulda ES, Bloomfield GS, Fichtenbaum CJ, Overton ET, Aberg JA, Malvestutto CD, Burdo TH, Arduino RC, Ho KS, Yin MT, Ribaudo HJ, Grinspoon SK. Ideal cardiovascular health, biomarkers, and coronary artery disease in persons with HIV. AIDS. 2023 Mar 1;37(3):423-434. doi: 10.1097/QAD.0000000000003418. Epub 2022 Nov 18. |
| 36462699 | Result | Fulda ES, Fichtenbaum CJ, Kileel EM, Zanni MV, Aberg JA, Malvestutto C, Cardoso SW, Berzins B, Lira R, Harden R, Robbins G, Martinez M, Nieves SD, McCallum S, Cruz JL, Umbleja T, Sprenger H, Giguel F, Bone F, Wood K, Byroads M, Paradis K, Lu MT, Douglas PS, Ribaudo HJ, Grinspoon SK, Fitch KV; REPRIEVE Investigators. The importance of methods for site performance evaluation in REPRIEVE, a longitudinal, global, multicenter trial. Contemp Clin Trials. 2023 Jan;124:107035. doi: 10.1016/j.cct.2022.107035. Epub 2022 Nov 30. |
| 36805331 | Result | Schnittman SR, Jung W, Fitch KV, Zanni MV, McCallum S, Lee JS, Shin S, Davis BJ, Fulda ES, Diggs MR, Giguel F, Chinchay R, Sheth AN, Fichtenbaum CJ, Malvestutto C, Aberg JA, Currier J, Lauffenburger DA, Douglas PS, Ribaudo HJ, Alter G, Grinspoon SK. Effect of host factors and COVID-19 infection on the humoral immune repertoire in treated HIV. JCI Insight. 2023 Mar 8;8(5):e166848. doi: 10.1172/jci.insight.166848. |
| 36825498 | Result | Kileel EM, Malvestutto CD, Lo J, Fitch KV, Fichtenbaum CJ, Aberg JA, Zanni MV, Martinez E, Okeke NL, Kumar P, Joao E, Bares SH, Berrner D, Smieja M, Roa JC, McCallum S, Douglas PS, Ribaudo HJ, Grinspoon SK. Changes in Body Mass Index with Longer-term Integrase Inhibitor Use: A Longitudinal Analysis of Data from the Randomized Trial to Prevent Vascular Events in Human Immunodeficiency Virus (REPRIEVE). Clin Infect Dis. 2023 Jun 8;76(11):2010-2013. doi: 10.1093/cid/ciad107. |
| 36998633 | Result | Schnittman SR, Kitch DW, Swartz TH, Burdo TH, Fitch KV, McCallum S, Flynn JM, Fulda ES, Diggs MR, Stapleton JT, Casado JL, Taron J, Currier JS, Zanni MV, Malvestutto C, Fichtenbaum CJ, Aberg JA, Ribaudo HJ, Lu MT, Douglas PS, Grinspoon SK. Coronary Artery Plaque Composition and Severity Relate to the Inflammasome in People With Treated Human Immunodeficiency Virus. Open Forum Infect Dis. 2023 Mar 1;10(3):ofad106. doi: 10.1093/ofid/ofad106. eCollection 2023 Mar. |
| 36966617 | Result | Kolossvary M, deFilippi C, McCallum S, Fitch KV, Diggs MR, Fulda ES, Ribaudo HJ, Fichtenbaum CJ, Aberg JA, Malvestutto CD, Currier JS, Casado JL, Gutierrez F, Sereti I, Douglas PS, Zanni MV, Grinspoon SK. Identification of pre-infection markers and differential plasma protein expression following SARS-CoV-2 infection in people living with HIV. EBioMedicine. 2023 Apr;90:104538. doi: 10.1016/j.ebiom.2023.104538. Epub 2023 Mar 24. |
| 37439633 | Result | Foldyna B, Mayrhofer T, Zanni MV, Lyass A, Barve R, Karady J, McCallum S, Burdo TH, Fitch KV, Paradis K, Fulda ES, Diggs MR, Bloomfield GS, Malvestutto CD, Fichtenbaum CJ, Aberg JA, Currier JS, Ribaudo HJ, Hoffmann U, Lu MT, Douglas PS, Grinspoon SK. Pericoronary Adipose Tissue Density, Inflammation, and Subclinical Coronary Artery Disease Among People With HIV in the REPRIEVE Cohort. Clin Infect Dis. 2023 Dec 15;77(12):1676-1686. doi: 10.1093/cid/ciad419. |
| 37486775 | Result | Grinspoon SK, Fitch KV, Zanni MV, Fichtenbaum CJ, Umbleja T, Aberg JA, Overton ET, Malvestutto CD, Bloomfield GS, Currier JS, Martinez E, Roa JC, Diggs MR, Fulda ES, Paradis K, Wiviott SD, Foldyna B, Looby SE, Desvigne-Nickens P, Alston-Smith B, Leon-Cruz J, McCallum S, Hoffmann U, Lu MT, Ribaudo HJ, Douglas PS; REPRIEVE Investigators. Pitavastatin to Prevent Cardiovascular Disease in HIV Infection. N Engl J Med. 2023 Aug 24;389(8):687-699. doi: 10.1056/NEJMoa2304146. Epub 2023 Jul 23. |
| 37503623 | Result | Lake JE, Taron J, Ribaudo HJ, Leon-Cruz J, Utay NS, Swaminathan S, Fitch KV, Kileel EM, Paradis K, Fulda ES, Ho KS, Luetkemeyer AF, Johnston CD, Zanni MV, Douglas PS, Grinspoon SK, Lu MT, Fichtenbaum CJ; REPRIEVE Trial Investigators. Hepatic steatosis and nonalcoholic fatty liver disease are common and associated with cardiometabolic risk in a primary prevention cohort of people with HIV. AIDS. 2023 Nov 15;37(14):2149-2159. doi: 10.1097/QAD.0000000000003671. Epub 2023 Jul 27. |
| 37869406 | Result | Schnittman SR, Kolossvary M, Beck-Engeser G, Fitch KV, Ambayec GC, Nance RM, Zanni MV, Diggs M, Chan F, McCallum S, Toribio M, Bamford L, Fichtenbaum CJ, Eron JJ, Jacobson JM, Mayer KH, Malvestutto C, Bloomfield GS, Moore RD, Umbleja T, Saag MS, Aberg JA, Currier JS, Delaney JAC, Martin JN, Lu MT, Douglas PS, Ribaudo HJ, Crane HM, Hunt PW, Grinspoon SK. Biological and Clinical Implications of the Vascular Endothelial Growth Factor Coreceptor Neuropilin-1 in Human Immunodeficiency Virus. Open Forum Infect Dis. 2023 Sep 8;10(10):ofad467. doi: 10.1093/ofid/ofad467. eCollection 2023 Oct. |
| 38197863 | Result | Bhattacharya R, Uddin MM, Patel AP, Niroula A, Finneran P, Bernardo R, Fitch KV, Lu MT, Bloomfield GS, Malvestutto C, Aberg JA, Fichtenbaum CJ, Hornsby W, Ribaudo HJ, Libby P, Ebert BL, Zanni MV, Douglas PS, Grinspoon SK, Natarajan P. Risk factors for clonal hematopoiesis of indeterminate potential in people with HIV: a report from the REPRIEVE trial. Blood Adv. 2024 Feb 27;8(4):959-967. doi: 10.1182/bloodadvances.2023011324. |
| 38381407 | Result | Lu MT, Ribaudo H, Foldyna B, Zanni MV, Mayrhofer T, Karady J, Taron J, Fitch KV, McCallum S, Burdo TH, Paradis K, Hedgire SS, Meyersohn NM, DeFilippi C, Malvestutto CD, Sturniolo A, Diggs M, Siminski S, Bloomfield GS, Alston-Smith B, Desvigne-Nickens P, Overton ET, Currier JS, Aberg JA, Fichtenbaum CJ, Hoffmann U, Douglas PS, Grinspoon SK; REPRIEVE Trial Writing Group. Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers in HIV: Mechanistic Substudy of the REPRIEVE Randomized Clinical Trial. JAMA Cardiol. 2024 Apr 1;9(4):323-334. doi: 10.1001/jamacardio.2023.5661. |
| 38533953 | Result | Zou RS, Ruan Y, Truong B, Bhattacharya R, Lu MT, Karady J, Bernardo R, Finneran P, Hornsby W, Fitch KV, Ribaudo HJ, Zanni MV, Douglas PS, Grinspoon SK, Patel AP, Natarajan P. Polygenic Scores and Preclinical Cardiovascular Disease in Individuals With HIV: Insights From the REPRIEVE Trial. J Am Heart Assoc. 2024 Apr 2;13(7):e033413. doi: 10.1161/JAHA.123.033413. Epub 2024 Mar 27. |
| 38692296 | Result | Grinspoon SK, Ribaudo HJ, Douglas PS. Trial Update of Pitavastatin to Prevent Cardiovascular Events in HIV Infection. N Engl J Med. 2024 May 2;390(17):1626-1628. doi: 10.1056/NEJMc2400870. No abstract available. |
| 41324519 | Derived | Foldyna B, Hadzic I, Mayrhofer T, Karady J, Taron J, Kolossvary M, Raghu VK, McCallum S, Paradis K, Diggs MR, Chu SM, Lu AB, Somboonwit C, Bernardino JI, Dube MP, Sponseller CA, Zanni MV, Bloomfield GS, Malvestutto CD, Fichtenbaum CJ, Aberg JA, Currier JS, Ribaudo HJ, Douglas PS, Lu MT, Grinspoon SK. Statin Effects on Pericoronary Adipose Tissue Density in People With HIV: Insights From the REPRIEVE Trial. JACC Cardiovasc Imaging. 2026 Apr;19(4):478-489. doi: 10.1016/j.jcmg.2025.10.012. Epub 2025 Dec 1. |
| 41217428 | Derived | Diggs MR, Chu SM, Fitch KV, Olefsky M, Watanabe MG, Erlandson KM, Lu AB, Bloomfield GS, Currier JS, Curran A, Eckard AR, Smith GHR, Sponseller CA, Fichtenbaum CJ, Malvestutto CD, Aberg JA, Foldyna B, Taron J, Karady J, Zanni MV, Douglas PS, Ribaudo HJ, Lu MT, Grinspoon SK. Health-related quality of life among people with HIV at low-to-moderate risk for atherosclerotic cardiovascular disease in the REPRIEVE Trial. AIDS. 2026 Apr 1;40(4):428-439. doi: 10.1097/QAD.0000000000004401. Epub 2025 Nov 14. |
| 41195533 | Derived | Xue L, Bhattacharya R, Uddin MM, Nakao T, Zou R, Patel A, Haidermota S, Niroula A, Viscosi V, Postupaka D, Bhatnagar A, Finneran P, Bernardo R, Diggs MR, Fitch KV, Chu SM, McCallum S, Currier JS, Fichtenbaum CJ, Malvestutto CD, Aberg JA, Bloomfield GS, Ribaudo HJ, Zanni MV, Libby P, Hornsby W, Lu MT, Douglas PS, Grinspoon SK, Natarajan P. Clonal Hematopoiesis and Major Adverse Cardiac Events in People With HIV: Insights From the REPRIEVE Trial. Arterioscler Thromb Vasc Biol. 2026 Jan;46(1):168-177. doi: 10.1161/ATVBAHA.125.322896. Epub 2025 Nov 6. |
| 41004413 | Derived | Grinspoon SK, Zhao S, Martinez E, Fichtenbaum CJ, Chu SM, Diggs MR, Umbleja T, McCallum S, Fitch KV, Triant VA, Currier JS, Aberg JA, Malvestutto CD, Erlandson KM, Bloomfield GS, Lu MT, Douglas PS, Ribaudo HJ, Zanni MV. Risk Assessment in a Global CVD Prevention Cohort of People With HIV by PCE, PREVENT, and SCORE2. Clin Infect Dis. 2026 Feb 25;82(2):e248-e257. doi: 10.1093/cid/ciaf542. |
| 40924496 | Derived | Kolossvary M, Sereti I, Zanni MV, Fichtenbaum CJ, Aberg JA, Bloomfield GS, Malvestutto CD, Currier JS, Chu SM, Diggs MR, Lu AB, deFilippi C, Foldyna B, McCallum S, Sponseller CA, Lu MT, Douglas PS, Ribaudo HJ, Grinspoon SK. Statin-dependent and -independent pathways are associated with major adverse cardiovascular events in people with HIV. J Clin Invest. 2025 Sep 9;135(22):e196021. doi: 10.1172/JCI196021. eCollection 2025 Nov 17. |
| 40888096 | Derived | Davies Smith E, Douglas PS, McCallum S, Troendle J, Diggs MR, Lu AB, Chu SM, Umbleja T, Lu MT, Zanni MV, Grinspoon SK, Ribaudo HJ. Win Ratio Aligns With and Enhances Interpretation of REPRIEVE's Primary Findings. Clin Infect Dis. 2026 Feb 9;82(1):e89-e92. doi: 10.1093/cid/ciaf477. |
| 40576558 | Derived | Corley MJ, Watanabe M, Pang APS, Dwaraka VB, Smith R, Samaneka W, Henn S, Munsiff S, Saumoy M, McCallum S, Fitch KV, Chu SM, Diggs MR, Aberg JA, Malvestutto CD, Fichtenbaum CJ, Currier JS, Zanni MV, Douglas PS, Lu MT, Landay AL, Erlandson KM, Ribaudo HJ, Grinspoon SK. Effect of Pitavastatin on Epigenetic Aging Biomarkers in People With HIV: Pilot Substudy of the REPRIEVE Trial. Clin Infect Dis. 2026 Feb 4;81(6):e560-e567. doi: 10.1093/cid/ciaf247. |
| 40482662 | Derived | Fichtenbaum CJ, Malvestutto CD, Watanabe MG, Davies Smith E, Ribaudo HJ, McCallum S, Fitch KV, Currier JS, Diggs MR, Chu SM, Aberg JA, Lu MT, Valencia J, Gomez-Ayerbe C, Brar I, Valdez Madruga J, Bloomfield GS, Douglas PS, Zanni MV, Grinspoon SK; REPRIEVE Investigators. Effects of antiretrovirals on major adverse cardiovascular events in the REPRIEVE trial: a longitudinal cohort analysis. Lancet HIV. 2025 Jul;12(7):e496-e505. doi: 10.1016/S2352-3018(25)00043-8. Epub 2025 Jun 4. |
| 40373520 | Derived | Lu MT, Ribaudo HJ, McCallum S, Zanni MV, deFilippi C, Taron J, Karady J, Foldyna B, Paradis K, Chu SM, Diggs MR, Burdo TH, Currier JS, Bloomfield GS, Fichtenbaum CJ, Malvestutto CD, Aberg JA, Mayrhofer T, Douglas PS, Grinspoon SK; REPRIEVE Investigators. Coronary Plaque, Inflammation, Subclinical Myocardial Injury, and Major Adverse Cardiovascular Events in the REPRIEVE Substudy. JACC Adv. 2025 Jun;4(6 Pt 1):101781. doi: 10.1016/j.jacadv.2025.101781. Epub 2025 May 14. |
| 40281648 | Derived | Grinspoon SK, Watanabe M, Ribaudo HJ, Bloomfield GS, Fichtenbaum CJ, Umbleja T, Chu SM, Fitch KV, Diggs MR, Zhao S, Looby SE, Currier JS, Aberg JA, Malvestutto CD, Erlandson KM, Martinez E, Asupoto O, Gupta SK, Lopez-Bernaldo de Quiros JC, Nixon D, Bedimo R, Lu MT, Douglas PS, Zanni MV. Factors Affecting Risk of Cardiovascular Disease (CVD) Events in a Global CVD Prevention Cohort of People With HIV. Clin Infect Dis. 2026 Feb 4;81(6):e548-e557. doi: 10.1093/cid/ciaf210. |
| 40207047 | Derived | Davies Smith E, Malvestutto C, Ribaudo HJ, Fichtenbaum CJ, Aberg JA, Watanabe M, Bloomfield GS, Currier JS, Chu SM, Fitch KV, Diggs MR, Bedimo R, Valencia J, Gomez-Ayerbe C, Brar I, Madruga JV, Lu MT, Douglas PS, Zanni MV, Grinspoon SK. Cardiovascular Hazards of Abacavir- Versus Tenofovir-Containing Antiretroviral Therapies: Insights From an Analysis of the REPRIEVE Trial Cohort. Open Forum Infect Dis. 2025 Mar 21;12(4):ofaf177. doi: 10.1093/ofid/ofaf177. eCollection 2025 Apr. |
| 40180472 | Derived | Diggs MR, Umbleja T, McCallum S, Zanni MV, Chu SM, Fitch KV, Bloomfield GS, Currier JS, Martinez E, Castle PE, Awwad A, Jain MK, Bedimo R, Hendricks B, Narrea J, Estrada V, Pinto J, Aberg JA, Malvestutto CD, Fichtenbaum CJ, Lu MT, Ribaudo HJ, Douglas PS, Grinspoon SK. Statin effects on the incidence of major non-cardiovascular disease events among a global cohort of people with HIV: a randomised controlled trial. Lancet HIV. 2025 Apr;12(4):e261-e272. doi: 10.1016/S2352-3018(24)00345-X. |
| 39832519 | Derived | Grinspoon SK, Zanni MV, Triant VA, Kantor A, Umbleja T, Diggs MR, Chu SM, Fitch KV, Currier JS, Bloomfield GS, Casado JL, de la Pena M, Fantry LE, Gardner E, Aberg JA, Malvestutto CD, Fichtenbaum CJ, Lu MT, Ribaudo HJ, Douglas PS. Performance of the pooled cohort equations and D:A:D risk scores among individuals with HIV in a global cardiovascular disease prevention trial: a cohort study leveraging data from REPRIEVE. Lancet HIV. 2025 Feb;12(2):e118-e129. doi: 10.1016/S2352-3018(24)00276-5. Epub 2025 Jan 17. |
| 39661372 | Derived | Kolossvary M, Schnittman SR, Zanni MV, Fitch KV, Fichtenbaum CJ, Aberg JA, Bloomfield GS, Malvestutto CD, Currier J, Diggs MR, deFilippi C, Eckard AR, Curran A, Centinbas M, Sadreyev R, Foldyna B, Mayrhofer T, Karady J, Taron J, McCallum S, Lu MT, Ribaudo HJ, Douglas PS, Grinspoon SK. Pitavastatin, Procollagen Pathways, and Plaque Stabilization in Patients With HIV: A Secondary Analysis of the REPRIEVE Randomized Clinical Trial. JAMA Cardiol. 2025 Mar 1;10(3):254-264. doi: 10.1001/jamacardio.2024.4115. |
| 39435321 | Derived | Zanni MV, Umbleja T, Fichtenbaum CJ, Fitch KV, McCallum S, Aberg JA, Overton ET, Malvestutto CD, Bloomfield GS, Currier JS, Schnittman SR, Erlandson KM, Diggs MR, Foldyna B, Martinez E, Somboonwit C, Wang GP, Mushatt D, Connick E, Lu MT, Douglas PS, Ribaudo HJ, Grinspoon SK. Effects of Pitavastatin on COVID-19 Incidence and Seriousness Among a Global Cohort of People With HIV. Open Forum Infect Dis. 2024 Oct 10;11(10):ofae574. doi: 10.1093/ofid/ofae574. eCollection 2024 Oct. |
| 39374532 | Derived | Fitch KV, Zanni MV, Manne-Goehler J, Diggs MR, Gattu AK, Currier JS, Bloomfield GS, Hsiao CB, Gupta SK, Aberg JA, Malvestutto CD, Fichtenbaum CJ, Lu MT, Douglas PS, Ribaudo HJ, Grinspoon SK. Diabetes Risk Factors in People With HIV Receiving Pitavastatin Versus Placebo for Cardiovascular Disease Prevention : A Randomized Trial. Ann Intern Med. 2024 Nov;177(11):1449-1461. doi: 10.7326/ANNALS-24-00944. Epub 2024 Oct 8. |
| 39253712 | Derived | deFilippi C, McCallum S, Zanni MV, Fitch KV, Diggs MR, Bloomfield GS, Fichtenbaum CJ, Aberg JA, Malvestutto CD, Pinto-Martinez A, Stapleton A, Duggan J, Robbins GK, Taron J, Karady J, Foldyna B, Lu MT, Ribaudo HJ, Douglas PS, Grinspoon SK. Association of Cardiac Troponin T With Coronary Atherosclerosis in Asymptomatic Primary Prevention People With HIV. JACC Adv. 2024 Aug 16;3(9):101206. doi: 10.1016/j.jacadv.2024.101206. eCollection 2024 Sep. |
| 39159048 | Derived | Erlandson KM, Umbleja T, Ribaudo HJ, Schrack JA, Overton ET, Fichtenbaum CJ, Fitch KV, Roa JC, Diggs MR, Wood K, Zanni MV, Bloomfield GS, Malvestutto C, Aberg JA, Rodriguez-Barradas MC, Morones RG, Breaux K, Douglas PS, Grinspoon SK, Brown TT. Pitavastatin Is Well-Tolerated With no Detrimental Effects on Physical Function. Clin Infect Dis. 2025 Feb 24;80(2):425-433. doi: 10.1093/cid/ciae422. |
| 38180893 | Derived | Abidi MZ, Umbleja T, Overton ET, Burdo T, Flynn JM, Lu MT, Taron J, Schnittman SR, Fitch KV, Zanni MV, Fichtenbaum CJ, Malvestutto C, Aberg JA, Fulda ES, Eckard AR, Manne-Goehler J, Tuan JJ, Ribaudo HJ, Douglas PS, Grinspoon SK, Brown TT, Erlandson KM. Cytomegalovirus IgG is Associated With Physical Function But Not Muscle Density in People With HIV. J Acquir Immune Defic Syndr. 2024 Apr 15;95(5):470-478. doi: 10.1097/QAI.0000000000003377. |
| 37368931 | Derived | Erlandson KM, Umbleja T, Lu MT, Taron J, Ribaudo HJ, Overton ET, Presti RM, Haas DW, Sax PE, Yin MT, Zhai BK, Louis R, Upadhyay N, Eslami P, Douglas PS, Zanni MV, Fitch KV, Fulda ES, Fichtenbaum CJ, Malvestutto CD, Grinspoon SK, Brown TT. Associations of Muscle Density and Area With Coronary Artery Plaque and Physical Function. J Acquir Immune Defic Syndr. 2023 Oct 1;94(2):174-184. doi: 10.1097/QAI.0000000000003244. |
| 32645163 | Derived | Umbleja T, Brown TT, Overton ET, Ribaudo HJ, Schrack JA, Fitch KV, Douglas PS, Grinspoon SK, Henn S, Arduino RC, Rodriguez B, Benson CA, Erlandson KM. Physical Function Impairment and Frailty in Middle-Aged People Living With Human Immunodeficiency Virus in the REPRIEVE Trial Ancillary Study PREPARE. J Infect Dis. 2020 Jul 9;222(Suppl 1):S52-S62. doi: 10.1093/infdis/jiaa249. |
| Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 | View source |
| Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A | View source |
Participants received placebo for pitavastatin once a day for the entire time they were in study follow-up.
Placebo: One tablet taken once daily, orally with or without food
| Enrolled in Mechanistic Substudy |
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| Completed Mechanistic Substudy |
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| COMPLETED |
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| NOT COMPLETED |
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All participants enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin | Participants received pitavastatin once a day for the entire time they were in study follow-up. Pitavastatin: One tablet (4 mg) taken once daily, orally with or without food |
| BG001 | Placebo | Participants received placebo for pitavastatin once a day for the entire time they were in study follow-up. Placebo: One tablet taken once daily, orally with or without food |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex/Gender, Customized | Gender identity was reported by the participants. | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Sex assigned at birth. | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Ethnicity was reported by the participants according to the National Institutes of Health definition for participants in the United States (including Puerto Rico) and Canada. "Unknown or Not Reported" include participants who reported that their ethnicity is unknown or that they do not wish to report their ethnicity. | Participants in the United States (including Puerto Rico) and Canada. Because the ethnicity definition is not applicable to other geographic regions, they were excluded from the measure analysis population. | Count of Participants | Participants |
| ||||||||||||||
| Race/Ethnicity, Customized | Race was reported by the participants. "Other" race includes participants who identified as native or indigenous to the enrollment region, as having more than one race, or as having an unknown race. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Global burden of disease (GBD) region | Count of Participants | Participants |
| ||||||||||||||||
| Atherosclerotic Cardiovascular Disease (ASCVD) risk score | 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) risk score is calculated based on age, sex, race, systolic blood pressure, total and high-density lipoprotein cholesterol, hypertension treatment, smoking history and presence of diabetes. It is measured on a continuous scale, with 0-<5% considered low risk, 5-<7.5% borderline risk, 7.5-<20% intermediate risk, and ≥20% high risk according to the American College of Cardiology and American Heart Association. More granular categories were used to describe REPRIEVE participants, given the eligibility criterion of low to moderate CVD risk. | Count of Participants | Participants |
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| Nadir CD4 cell count | Count of Participants | Participants |
| ||||||||||||||||
| CD4 cell count | Count of Participants | Participants |
| ||||||||||||||||
| HIV-1 RNA | The assays that were used for testing varied, including assays with a lower limit of quantification (LLQ) of 20 to 400 copies/mL. | The level of HIV-1 RNA was collected if data were available through standard care. | Count of Participants | Participants |
| ||||||||||||||
| Pre-existing diabetes | Count of Participants | Participants |
| ||||||||||||||||
| Mechanistic Substudy: Presence of Non-calcified Plaque (NCP) | Presence of NCP defined as evidence of NCP based on the qualitative read of the CT scan. Note that presence of NCP based on the qualitative read does not necessarily mean that NCP volume can be quantified based on the quantitative read or vice versa. | Participants enrolled in the Mechanistic Substudy with paired CT scans (entry and year 2) and data on this measure available. | Count of Participants | Participants |
| ||||||||||||||
| Mechanistic Substudy: NCP Volume | NCP was defined as plaque voxels with attenuation <350 Hounsfield Units (HU) based on the quantitative read of the CT scan. If no quantitative result was available, structural zeroes were assigned if no NCP was present based on the qualitative read. | Participants enrolled in the Mechanistic Substudy with paired CT scans (entry and year 2) and data on this measure available. | Mean | Standard Deviation | mm^3 |
| |||||||||||||
| Mechanistic Substudy: Total Plaque Volume | Participants enrolled in the Mechanistic Substudy with paired CT scans (entry and year 2) and data on this measure available. | Mean | Standard Deviation | mm^3 |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence Rate of Major Adverse Cardiovascular Event (MACE) | MACE is a composite of cardiovascular (CV) death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack (TIA), peripheral arterial ischemia, coronary, carotid or peripheral arterial revascularization, or death from an undetermined cause. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Non-CV deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate of Cardiac Ischemia or Myocardial Infarction | Cardiac ischemia or myocardial infarction component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence Rate of Cerebrovascular Event (Stroke or TIA) | Cerebrovascular event (stroke or TIA) component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Peripheral Arterial Ischemia | Peripheral arterial ischemia component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Death From CV Causes | CV death component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Non-CV deaths and deaths from undetermined causes were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Death From CV or Undetermined Causes | CV or undetermined death component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Non-CV deaths were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Cardiac Catheterization or Revascularization | Cardiac cardiac catheterization or revascularization component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Carotid or Cerebrovascular Revascularization | Carotid or cerebrovascular revascularization component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Peripheral Arterial Revascularization | Peripheral arterial revascularization component of the primary composite MACE outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of MACE or Death | A composite outcome including MACE and death from any cause. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Death (All-cause) | Death from any cause. The incidence rates were estimated based on time to event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Non-CV Clinical Diagnoses | A composite of non-CV clinical diagnoses including: non-AIDS-defining cancers (excluding basal cell and squamous cell carcinomas of the skin), AIDS-defining events (based on Centers for Disease Control and Prevention [CDC] 2014 classification), end-stage renal disease, and end-stage liver disease. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Non-AIDS-defining Cancer | Non-AIDS-defining cancer (excluding basal cell and squamous cell carcinomas of the skin) component of the composite non-CV clinical diagnoses outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of AIDS-defining Event | AIDS-defining event component of the composite non-CV clinical diagnoses outcome. Events were captured based on the Centers for Disease Control and Prevention [CDC] 2014 classification. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of End-Stage Renal Disease | End-stage renal disease (defined as initiation of dialysis or renal transplantation) component of the composite non-CV clinical diagnoses outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of End-Stage Liver Disease | End-stage liver disease (defined as cirrhosis or hepatic decompensation requiring hospitalization) component of the composite non-CV clinical diagnoses outcome. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Non-fatal Serious Adverse Event | Safety analysis outcome measure of non-fatal serious adverse event was defined by International Conference on Harmonisation (ICH) criteria. Fatal events were excluded as deaths were a secondary efficacy outcome (see outcome measure: incidence rate of death (all-cause)). The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo), adjusted for screening CD4 and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 100 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Diabetes | Safety analysis outcome measure of diabetes was defined as new diagnosis of diabetes with initiation of anti-diabetic agent. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo), adjusted for screening CD4 and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Participants without pre-existing diabetes at baseline, according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 100 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Myalgia, Muscle Weakness or Myopathy | Safety analysis outcome measure of myalgia, muscle weakness or myopathy which were grade 3 or higher or treatment-limiting. Grade 3 or higher includes grade 3 and 4 events, where grade 3 refers to severe and grade 4 to life-threatening according to DAIDS AE Grading Table (version 2.1). The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo), adjusted for screening CD4 and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 100 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Rhabdomyolysis | Safety analysis outcome measure of rhabdomyolysis which was grade 3 or higher or treatment-limiting. Grade 3 or higher includes grade 3 and 4 events, where grade 3 refers to severe and grade 4 to life-threatening, according to DAIDS AE Grading Table (version 2.1). The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo). Due to small number of events, there was no adjustment for screening CD4 and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 100 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Grade 3 or Higher ALT | Safety analysis outcome measure of Grade 3 or higher alanine transaminase (ALT). Grade 3 or higher includes grade 3 and 4 events, where grade 3 refers to severe and grade 4 to life-threatening, according to DAIDS AE Grading Table (version 2.1). The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo). Due to small number of events, there was no adjustment for screening CD4 and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 100 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Incidence Rate of Adverse Event (AE) | Safety analysis outcome measure of any AE. AE collection included events of grade ≥3, those that were serious (defined by International Conference on Harmonisation (ICH) criteria) or treatment-limiting, and targeted diagnosis of diabetes. Grade ≥3 includes events that were grade 3 (serious) or grade 4 (life-threatening) per DAIDS AE Grading Table (version 2.1). Fatal events were excluded as deaths were a secondary efficacy outcome (see outcome measure: incidence rate of death (all-cause)). The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo), adjusted for screening CD4 and sex. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 100 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Secondary | Fasting Low-density Lipoprotein Cholesterol (LDL-C) | LDL-C level was derived as LDL-C calculated according to the Friedewald formula at triglycerides ≤400 mg/dL, and direct LDL-C at triglycerides >400 to <500 mg/dL. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. The number of participants with fasting LDL-C available is shown at each timepoint. | Posted | Median | Inter-Quartile Range | mg/dL | At entry and months 12, 24, 36, 48, 60, 72, 84. Participants' follow-up time on study varied, depending on their time of enrollment. |
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| Secondary | Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Non-HDL cholesterol levels were calculated as total cholesterol minus HDL cholesterol. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | All participants enrolled according to the randomized treatment group. The number of participants with fasting non-HDL-C available is shown at each timepoint. | Posted | Median | Inter-Quartile Range | mg/dL | At entry and months 12, 24, 36, 48, 60, 72, 84. Participants' follow-up time on study varied, depending on their time of enrollment. |
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| Secondary | Incidence Rate of Serious COVID-19 | Serious COVID-19 was defined as COVID-19 that resulted in hospitalization or death or was life-threatening as per the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline E2A definition. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios from Poisson regression models (prescribed pitavastatin compared to placebo), adjusted for GBD region to account for regional differences. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Participants who remained in REPRIEVE follow-up at the start of the COVID-19 pandemic (defined as January 1, 2020), according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 100 person-years | From January 1, 2020 through end of study; the median follow-up time was 3.3 years. |
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| Secondary | Incidence Rate of COVID-19 | COVID-19 was defined as COVID-19 clinical diagnosis or positive test result (SARS-CoV-2 PCR or rapid antigen tests). The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated using incidence rate ratios (prescribed pitavastatin compared to placebo) from Poisson regression models, adjusted for GBD region to account for regional differences. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Participants who remained in REPRIEVE follow-up at the start of the COVID-19 pandemic (defined as January 1, 2020), according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 100 person-years | From January 1, 2020 through end of study; the median follow-up time was 3.3 years. |
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| Secondary | For Mechanistic Substudy: Change in Non-Calcified Plaque (NCP) Volume From Baseline to Year 2 | NCP was defined as plaque voxels with attenuation of <350. Change in NCP is expressed as absolute change from baseline (calculated as NCP volume at 2 years minus NCP volume at entry), based on quantitative read of the CT scan, whenever available. Participants without a quantitative read and no evidence of NCP based on the corresponding qualitative read were assigned a value of zero for the change. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Participants enrolled in the Mechanistic Substudy, with complete case outcome data (paired entry and year 2). | Posted | Mean | Standard Deviation | mm^3 | Entry and Year 2. |
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| Secondary | For Mechanistic Substudy: Number of Participants With Progression of NCP From Baseline to Year 2 | Progression at Year 2 was defined as any progression/increase in NCP volume in participants with evidence of NCP at entry, or incident NCP in participants without evidence of NCP at entry. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Participants enrolled in the Mechanistic Substudy, with complete case outcome data (paired entry and year 2). | Posted | Count of Participants | Participants | Entry and year 2. |
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| Secondary | For Mechanistic Substudy: Change in Total Plaque Volume From Baseline to Year 2 | Total plaque includes all plaque voxels (noncalcified + calcified). Change in total plaque volume is expressed as absolute change from baseline (calculated as volume at 2 years minus volume at entry). Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Participants enrolled in the Mechanistic Substudy, with complete case outcome data (paired entry and year 2). | Posted | Mean | Standard Deviation | mm^3 | Entry and year 2. |
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| Secondary | For Mechanistic Substudy: LpPLA2 Level | Level of inflammatory biomarker lipoprotein-associated phospholipase A2 (LpPLA2). Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Participants enrolled in the Mechanistic Substudy with biomarker results available. | Posted | Median | Inter-Quartile Range | ng/mL | Entry and month 24. |
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| Secondary | For Mechanistic Substudy: Change in LpPLA2 From Baseline | Change in inflammatory biomarker LpPLA2 from baseline calculated as value at month 24 minus value at entry. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Participants enrolled in the Mechanistic Substudy with biomarker results available at entry and month 24. | Posted | Median | Inter-Quartile Range | ng/mL | Entry and month 24. |
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| Secondary | For Mechanistic Substudy: HsCRP Level | Level of inflammatory marker high-sensitivity C-reactive protein (HsCRP). Censored values below or above the assay limit were imputed. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Participants enrolled in the Mechanistic Substudy with biomarker results available. | Posted | Median | Inter-Quartile Range | mg/dL | Entry and month 24. |
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| Secondary | For Mechanistic Substudy: Change in HsCRP From Baseline | Change in inflammatory biomarker hsCRP from baseline calculated as value at month 24 minus value at entry. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Participants enrolled in the Mechanistic Substudy with biomarker results available at entry and month 24. | Posted | Median | Inter-Quartile Range | mg/mL | Entry and month 24. |
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| Secondary | For Mechanistic Substudy: Soluble CD163 Level | Level of immune biomarker soluble CD163. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Participants enrolled in the Mechanistic Substudy with biomarker results available. | Posted | Median | Inter-Quartile Range | ng/mL | Entry and month 24. |
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| Secondary | For Mechanistic Substudy: Change in Soluble CD163 From Baseline | Change in immune biomarker soluble CD163 from baseline calculated as value at month 24 minus value at entry. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy). | Participants enrolled in the Mechanistic Substudy with biomarker results available at entry and month 24. | Posted | Median | Inter-Quartile Range | ng/mL | Entry and month 24. |
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| Other Pre-specified | Incidence Rate of MACE by Sex | Subgroup analysis of the primary composite MACE outcome measure (as described above) by sex. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The Cox proportional hazards models described for the primary outcome above were expanded to include sex and interaction of sex and treatment, to evaluate modification of statin effect. | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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| Other Pre-specified | Incidence Rate of MACE by Race | Subgroup analysis of the primary composite MACE outcome measure (as described above) by race. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The Cox proportional hazards models described for the primary outcome above were expanded to include race and interaction of race and treatment, to evaluate modification of statin effect. | All participants enrolled according to the randomized treatment group. | Posted | Number | 95% Confidence Interval | events per 1000 person-years | From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years). |
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From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
AE collection included events of grade ≥3, those that were serious (per ICH criteria) or treatment-limiting, and all new diagnoses of diabetes. Grade ≥3 includes events that were grade 3 (serious) or grade 4 (life-threatening) per DAIDS AE Grading Table (version 2.1). Targeted clinical events for pitavastatin efficacy evaluation (MACE, death, COVID-19, heart failure) were not considered AEs. MedDRA High Level Term (HLT) grouped by System Organ Class is presented in the summary tables.
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 | Pitavastatin | Participants received pitavastatin once a day for the entire time they were in study follow-up. Pitavastatin: One tablet (4 mg) taken once daily, orally with or without food | 126 | 3,888 | 750 | 3,888 | 488 | 3,888 |
| EG001 | Placebo | Participants received placebo for pitavastatin once a day for the entire time they were in study follow-up. Placebo: One tablet taken once daily, orally with or without food | 143 | 3,881 | 755 | 3,881 | 420 | 3,881 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia deficiencies | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Anaemias NEC | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Anaemias due to chronic disorders | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Coagulopathies | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Leukopenias NEC | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Lymphatic system disorders NEC | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Neutropenias | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Thrombocytopenias | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Cardiac conduction disorders | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Cardiac signs and symptoms NEC | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Coronary artery disorders NEC | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Heart failures NEC | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Ischaemic coronary artery disorders | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Left ventricular failures | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Mitral valvular disorders | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Noninfectious pericarditis | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Pericardial disorders NEC | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rate and rhythm disorders NEC | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Supraventricular arrhythmias | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ventricular arrhythmias and cardiac arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hearing losses | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Inner ear signs and symptoms | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Adrenal cortical hypofunctions | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperparathyroid disorders | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Posterior pituitary disorders | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cataract conditions | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Choroid and vitreous structural change, deposit and degeneration | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Glaucomas (excl congenital) | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Iris and uveal tract infections, irritations and inflammations | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Optic disc abnormalities NEC | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Optic nerve bleeding and vascular disorders | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Orbital infections, inflammations and irritations | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Retinal structural change, deposit and degeneration | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Visual impairment and blindness (excl colour blindness) | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal hernias NEC | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute and chronic pancreatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anal and rectal disorders NEC | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anal and rectal pains | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Benign neoplasms gastrointestinal (excl oral cavity) | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Colitis (excl infective) | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diaphragmatic hernias | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea (excl infective) | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Duodenal and small intestinal stenosis and obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Duodenal ulcers and perforation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastric and oesophageal haemorrhages | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastritis (excl infective) | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal and abdominal pains (excl oral and throat) | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal atonic and hypomotility disorders NEC | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal disorders NEC | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal inflammatory disorders NEC | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal signs and symptoms NEC | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal stenosis and obstruction NEC | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal ulcers and perforation, site unspecified | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal vascular occlusion and infarction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gingival disorders, signs and symptoms NEC | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemorrhoids and gastrointestinal varices (excl oesophageal) | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Inguinal hernias | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intestinal haemorrhages | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intestinal ulcers and perforation NEC | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Large intestinal stenosis and obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea and vomiting symptoms | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Non-site specific gastrointestinal haemorrhages | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oesophageal stenosis and obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oesophageal ulcers and perforation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oesophagitis (excl infective) | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oral soft tissue disorders NEC | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peritoneal and retroperitoneal disorders | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rectal inflammations NEC | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Salivary gland disorders NEC | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Umbilical hernias | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenic conditions | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Body temperature altered | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Febrile disorders | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| General signs and symptoms NEC | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Healing abnormal NEC | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hernias NEC | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Inflammations | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema NEC | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain and discomfort NEC | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ulcers NEC | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bile duct infections and inflammations | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholecystitis and cholelithiasis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholestasis and jaundice | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic and hepatobiliary disorders NEC | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic enzymes and function abnormalities | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic fibrosis and cirrhosis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic vascular disorders | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatocellular damage and hepatitis NEC | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Obstructive bile duct disorders (excl neoplasms) | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Structural and other bile duct disorders | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute and chronic sarcoidosis | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Allergic conditions NEC | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Allergies to foods, food additives, drugs and other chemicals | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaphylactic and anaphylactoid responses | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal and gastrointestinal infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Actinomycotic infectious disorders | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Adenoviral infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Atypical mycobacterial infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bacterial infections NEC | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bone and joint infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Breast infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Caliciviral infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Campylobacter infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Candida infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Central nervous system and spinal infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Clostridia infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cryptococcal infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cytomegaloviral infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Dental and oral soft tissue infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Ear infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Enterococcal infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Escherichia infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Eye and eyelid infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Female reproductive tract infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Flaviviral infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Fungal infections NEC | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Haemophilus infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatitis virus infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatobiliary and spleen infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes viral infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infections NEC | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza viral infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Legionella infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Leptospira infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Listeria infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Lower respiratory tract and lung infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Male reproductive tract infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle and soft tissue infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Neisseria infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nematode infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Orthopox viral infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Parainfluenzae viral infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Plasmodia infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumocystis infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Rhinoviral infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Rickettsial infectious disorders NEC | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Salmonella infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sepsis, bacteraemia, viraemia and fungaemia NEC | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Shigella infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Skin structures and soft tissue infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Staphylococcal infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Streptococcal infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Toxoplasma infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Treponema infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Tuberculous infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Vascular infections | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Viral infections NEC | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal and gastrointestinal injuries NEC | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Accidental exposures to product | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebral injuries NEC | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Chemical injuries | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Chest and respiratory tract injuries NEC | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Conditions caused by cold | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Eye injuries NEC | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Fractures and dislocations NEC | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal and hepatobiliary procedural complications | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Limb fractures and dislocations | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle, tendon and ligament injuries | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal procedural complications | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Non-site specific injuries NEC | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Non-site specific procedural complications | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Overdoses NEC | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Pelvic fractures and dislocations | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Poisoning and toxicity | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Product administration errors and issues | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Radiation injuries | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Site specific injuries NEC | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Skin injuries NEC | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Skull fractures, facial bone fractures and dislocations | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal cord injuries NEC | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal fractures and dislocations | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Thermal burns | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Thoracic cage fractures and dislocations | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Carbohydrate tolerance analyses (incl diabetes) | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac function diagnostic procedures | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| ECG investigations | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatobiliary function diagnostic procedures | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Physical examination procedures and organ system status | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet analyses | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Red blood cell analyses | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Renal function analyses | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Skeletal and cardiac muscle analyses | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Tissue enzyme analyses NEC | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Triglyceride analyses | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Vascular tests NEC (incl blood pressure) | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| White blood cell analyses | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Calcium metabolism disorders | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetes mellitus (incl subtypes) | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetic complications NEC | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetic complications neurological | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Disorders of purine metabolism | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Elevated triglycerides | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| General nutritional disorders NEC | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperglycaemic conditions NEC | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoglycaemic conditions NEC | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lipid metabolism and deposit disorders NEC | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Metabolic acidoses (excl diabetic acidoses) | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Metabolic alkaloses | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Phosphorus metabolism disorders | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Potassium imbalance | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sodium imbalance | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Total fluid volume decreased | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthropathies NEC | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bone disorders NEC | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cartilage disorders | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fracture complications | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fractures NEC | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intervertebral disc disorders NEC | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Joint related disorders NEC | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Joint related signs and symptoms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Metabolic bone disorders | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle infections and inflammations | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle pains | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle related signs and symptoms NEC | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle weakness conditions | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue pain and discomfort | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myopathies | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Osteoarthropathies | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rheumatoid arthropathies | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Spine and neck deformities | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Synovial disorders | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tendon disorders | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anal canal neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| B-cell lymphomas NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Bile duct neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Bladder neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Bone neoplasms unspecified malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Breast and nipple neoplasms benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Breast and nipple neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Burkitt's lymphomas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Central nervous system neoplasms malignant NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Cervix neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Colorectal neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Endocrine neoplasms malignant and unspecified NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Extranodal marginal zone B-cell lymphomas (low grade B-cell) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Fallopian tube neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Fibrous histiocytomas malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Gallbladder neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Gastric neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Glial tumours malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Gliomas benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Hodgkin's disease NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Laryngeal neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Leukaemias acute lymphocytic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Leukaemias chronic myeloid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Lip and oral cavity neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Liposarcomas malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphomas unspecified NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Mediastinal neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Metastases to specified sites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Myeloproliferative disorders (excl leukaemias) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Neoplasms malignant site unspecified NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Nervous system neoplasms unspecified malignancy NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Non-Hodgkin's lymphomas NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Non-small cell neoplasms malignant of the respiratory tract cell type specified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Oncologic complications and emergencies | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Oropharyngeal, nasopharyngeal and tonsillar neoplasms malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Ovarian neoplasms benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Ovarian neoplasms malignant (excl germ cell) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Plasma cell myelomas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Prostatic neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Renal neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Renal pelvis and ureter neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract and pleural neoplasms malignant cell type unspecified NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract small cell carcinomas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Salivary gland neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Skin melanomas (excl ocular) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Skin neoplasms benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Skin neoplasms malignant and unspecified (excl melanoma) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Soft tissue neoplasms benign NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Uterine neoplasms benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Vulval neoplasms malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Acute polyneuropathies | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Alzheimer's disease (incl subtypes) | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Central nervous system aneurysms and dissections | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Central nervous system haemorrhages and cerebrovascular accidents | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Central nervous system vascular disorders NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cervical spinal cord and nerve root disorders | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Coordination and balance disturbances | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cortical dysfunction NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cranial nerve disorders NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dementia (excl Alzheimer's type) | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Demyelinating disorders NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Disturbances in consciousness NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Encephalopathies NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Encephalopathies toxic and metabolic | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Facial cranial nerve disorders | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Generalised tonic-clonic seizures | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headaches NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hydrocephalic conditions | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Increased intracranial pressure disorders | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lumbar spinal cord and nerve root disorders | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Memory loss (excl dementia) | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Migraine headaches | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mononeuropathies | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Motor neurone diseases | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nervous system disorders NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neurological signs and symptoms NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neuromuscular disorders NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Optic nerve disorders NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Paraesthesias and dysaesthesias | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Paralysis and paresis (excl cranial nerve) | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Parkinson's disease and parkinsonism | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral neuropathies NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Seizures and seizure disorders NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Speech and language abnormalities | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal cord and nerve root disorders NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Structural brain disorders NEC | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Transient cerebrovascular events | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abortions spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 26.1 | Systematic Assessment |
| |
| Device issues NEC | Product Issues | MedDRA 26.1 | Systematic Assessment |
| |
| Abnormal behaviour NEC | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anxiety symptoms | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Behaviour and socialisation disturbances | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bipolar disorders | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Confusion and disorientation | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Deliria | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Delusional disorders | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Delusional symptoms | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Depressive disorders | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mental disorders NEC | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mood alterations with manic symptoms | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mood disorders NEC | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Panic attacks and disorders | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Psychotic disorder NEC | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Schizoaffective and schizophreniform disorders | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Schizophrenia NEC | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Somatic symptom disorders | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Substance related and addictive disorders | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Suicidal and self-injurious behaviour | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bladder disorders NEC | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Genital and urinary tract disorders NEC | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Glomerulonephritis and nephrotic syndrome | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nephropathies and tubular disorders NEC | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal failure and impairment | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal lithiasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal obstructive disorders | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal vascular and ischaemic conditions | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Structural and obstructive urethral disorders (excl congenital) | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urethral disorders NEC | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary abnormalities | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract lithiasis NEC | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract signs and symptoms NEC | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Breast disorders NEC | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cervix disorders NEC | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Menstruation and uterine bleeding NEC | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Menstruation with increased bleeding | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ovarian and fallopian tube cysts and neoplasms | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pelvis and broad ligament disorders NEC | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Prostate and seminal vesicles infections and inflammations | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Prostatic neoplasms and hypertrophy | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Reproductive tract disorders NEC (excl neoplasms) | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Testicular and epididymal disorders NEC | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Uterine disorders NEC | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vulvovaginal disorders NEC | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Breathing abnormalities | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchial conditions NEC | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchospasm and obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Conditions associated with abnormal gas exchange | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Coughing and associated symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms) | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lower respiratory tract signs and symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nasal disorders NEC | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Parenchymal lung disorders NEC | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumothorax and pleural effusions NEC | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary hypertensions | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary oedemas | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary thrombotic and embolic conditions | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory failures (excl neonatal) | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract disorders NEC | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Angioedemas | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatitis and eczema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatitis ascribed to specific agent | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lipodystrophies | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus NEC | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Psoriatic conditions | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rashes, eruptions and exanthems NEC | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin and subcutaneous tissue ulcerations | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Criminal activity | Social circumstances | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal therapeutic procedures NEC | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Biliary tract and gallbladder therapeutic procedures | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac therapeutic procedures NEC | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac valve therapeutic procedures | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Facial therapeutic procedures | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Gastric therapeutic procedures | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Hernia repairs | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Joint therapeutic procedures | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Laryngeal therapeutic procedures | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Limb therapeutic procedures | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Penile therapeutic procedures | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Psychiatric therapies | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Renal therapeutic procedures | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Small intestine therapeutic procedures | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Soft tissue therapeutic procedures NEC | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Spine and spinal cord therapeutic procedures | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Therapeutic procedures NEC | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Uterine therapeutic procedures | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Accelerated and malignant hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aortic aneurysms and dissections | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aortic embolism and thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Circulatory collapse and shock | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemorrhages NEC | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphoedemas | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Non-site specific embolism and thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Non-site specific necrosis and vascular insufficiency NEC | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral embolism and thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral vasoconstriction, necrosis and vascular insufficiency | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Varicose veins NEC | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vascular hypertensive disorders NEC | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vascular hypotensive disorders | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vasculitides NEC | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Physical examination procedures and organ system status | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Renal function analyses | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetes mellitus (incl subtypes) | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| General nutritional disorders NEC | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle pains | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue pain and discomfort | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vascular hypertensive disorders NEC | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| REPRIEVE Project Manager | REPRIEVE Clinical Coordinating Center | 617-724-9109 | mghreprievetrial@mgb.org |
| Sep 24, 2024 |
| Prot_ICF_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: REPRIEVE SAP | Jun 6, 2022 | Jul 5, 2024 | SAP_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Mechanistic Substudy SAP | Oct 4, 2023 | Jul 5, 2024 | SAP_005.pdf |
| ICF | No | No | Yes | Informed Consent Form: Spanish | May 16, 2022 | Sep 24, 2024 | ICF_006.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D007249 | Inflammation |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C108475 | pitavastatin |
Not provided
Not provided
Not provided
|
| 50-59 years |
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| ≥60 years |
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| Transgender |
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| Not reported |
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| United States |
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| Thailand |
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| India |
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| Spain |
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| Botswana |
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| Brazil |
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| South Africa |
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| Uganda |
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| Zimbabwe |
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| Peru |
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Participants received placebo for pitavastatin once a day for the entire time they were in study follow-up.
Placebo: One tablet taken once daily, orally with or without food
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