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| ID | Type | Description | Link |
|---|---|---|---|
| EP08025.006 | Other Identifier | Merck | |
| 2010_021 | Other Identifier | Merck |
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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
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The objective of this study is to monitor Health Outcomes of Interest (HOI) in participants with human immunodeficiency virus-1 (HIV-1) infection following treatment with Raltegravir.
Study participants contributed data to one or more of 3 cohorts: 1) Historical Cohort: HIV-infected participants treated with antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of Kaiser Permanente (KP) between 1 January 2000 and 12 October 2007 (date of market authorization for raltegravir in USA), 2) Concurrent Cohort: HIV-infected participant treated with a new non-raltegravir antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007, and 3) Raltegravir Cohort: HIV-infected participant treated with raltegravir in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007. Participants could contribute data to more than one cohort, but no overlap in follow-up time was allowed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir Cohort Only | Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only. | ||
| Historical and Raltegravir Cohorts Only | Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only. | ||
| Historical Cohort Only | Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only. | ||
| Historical and Concurrent Cohorts Only | Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only. | ||
| Concurrent Cohort Only | Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AIDS-defining and Non-AIDS-defining Malignancy | All new malignancies occurring during the risk period, including Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancies, were identified through the Kaiser Permanente cancer registries. The registry data was supplemented by the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations to identify cancers that would not be captured through the cancer registries (e.g. cutaneous Kaposi's sarcoma).The AIDS-defining malignancies reported for any cohort were invasive cervical cancer, Kaposi's sarcoma, and non-Hodgkin lymphoma. Incidence is reported as unadjusted, crude rates. | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
| Incidence of Clinically Important Hepatic Events | Hepatic events occurring during the risk period were identified through computer-stored records of laboratory values, outpatient visits, Emergency Department visits, and hospitalizations. Significant hepatic events were identified based on algorithms utilizing a combination of diagnoses, procedures, and laboratory results. Incidence is reported as unadjusted, crude rates. | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
| Incidence of Clinically Important Skin Events | Significant skin events (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) occurring during the risk period were identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations. The identification of potential significant skin events was based on algorithms utilizing a combination of diagnoses, procedures and/or medications. Surveillance of outpatient visits was limited to rashes coded as drug-related and requiring use of steroid (e.g. prednisone) administration. Incidence is reported as unadjusted, crude rates. | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Clinically Important Cardiovascular Events | Significant cardiovascular events occurring during the risk period were identified through the use of computer-stored records and defined as inpatient events based on algorithms that utilize a combination of diagnosis and/or procedure codes. The identification of potential significant cardiovascular events was based on the occurrence of major adverse cardiovascular events (MACE) which include acute myocardial infarction (MI), ischemic stroke, unstable angina, revascularization (e.g. percutaneous coronary intervention (PCI) and coronary bypass graft surgery (CABG)), and cardiovascular death. Incidence is reported as unadjusted, crude rates. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults 18 years old and older
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| Label | URL |
|---|---|
| EUPAS Register (EUPAS17981) | View source |
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The analyses in this study are based on data collected from a cohort of human immunodeficiency virus (HIV-1)-infected participants in a setting of routine clinical care at the Kaiser Permanente medical centers in California, United States. Participants could contribute data to more than one cohort, but no overlap in follow-up time was allowed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Raltegravir Cohort Only | Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only. |
| FG001 | Historical and Raltegravir Cohorts Only | Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only. |
| FG002 | Historical Cohort Only | Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only. |
| FG003 | Historical and Concurrent Cohorts Only | Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only. |
| FG004 | Concurrent Cohort Only | Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only. |
| FG005 | Concurrent and Raltegravir Cohorts Only | Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only. |
| FG006 | Historical, Concurrent and Raltegravir Cohorts | Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Raltegravir Cohort Only | Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only. |
| BG001 | Historical and Raltegravir Cohorts Only |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 of AIDS-defining and Non-AIDS-defining Malignancy | All new malignancies occurring during the risk period, including Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancies, were identified through the Kaiser Permanente cancer registries. The registry data was supplemented by the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations to identify cancers that would not be captured through the cancer registries (e.g. cutaneous Kaposi's sarcoma).The AIDS-defining malignancies reported for any cohort were invasive cervical cancer, Kaposi's sarcoma, and non-Hodgkin lymphoma. Incidence is reported as unadjusted, crude rates. | The analysis includes all eligible participants. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years of followup | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
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Per protocol, adverse events were not collected as part of the study database; therefore, none were collected and the number at risk is zero.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Raltegravir Cohort | Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Concurrent and Raltegravir Cohorts Only | Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only. |
| Historical, Concurrent and Raltegravir Cohorts | Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts. |
| Incidence of Clinically Important Muscle Events | Significant muscle events (e.g. rhabdomyolysis) occurring during the risk period were identified through the use of computer-stored records of laboratory values, outpatient visits, Emergency Department visits and hospitalizations. The identification of potential significant muscle events was based on algorithms utilizing a combination of diagnoses, procedures and/or laboratory results for creatinine kinase. The number of muscle events did not meet the threshold for statistical analysis per protocol. Incidence is reported as unadjusted, crude rates. | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
| Incidence of Lipodystrophy | Lipodystrophy (e.g. lipoatrophy, facial wasting) occurring during the risk period was identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations. The identification of potential lipodystrophy was based on two coded diagnoses codes indicative of lipodystrophy appearing at least 6 months apart over the course of patient care, the identification of interventions to treat such conditions (e.g. sculptra therapy), or procedural codes for Computerized Tomography indicating incident neck or abdominal lipoaccumulation. Incidence is reported as unadjusted, crude rates. | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
| Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
| Incidence of All-cause Mortality | All-cause mortality occurring during the risk period was identified through the use of computer-stored records of Emergency Department visits, hospitalizations, and state death certificates. Deaths were identified from administrative Kaiser Permanente databases, including Kaiser Permanente regional research and respective state(s) mortality files as well as the Social Security Administrative files. Incidence is reported as unadjusted, crude rates. | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only. |
| BG002 | Historical Cohort Only | Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only. |
| BG003 | Historical and Concurrent Cohorts Only | Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only. |
| BG004 | Concurrent Cohort Only | Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only. |
| BG005 | Concurrent and Raltegravir Cohorts Only | Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only. |
| BG006 | Historical, Concurrent and Raltegravir Cohorts | Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts. |
| BG007 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Raltegravir Cohort |
Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort. |
| OG001 | Historical Cohort | Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts. |
| OG002 | Concurrent Cohort | Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort. |
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| Primary | Incidence of Clinically Important Hepatic Events | Hepatic events occurring during the risk period were identified through computer-stored records of laboratory values, outpatient visits, Emergency Department visits, and hospitalizations. Significant hepatic events were identified based on algorithms utilizing a combination of diagnoses, procedures, and laboratory results. Incidence is reported as unadjusted, crude rates. | The analysis includes all eligible participants. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years of followup | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
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| Primary | Incidence of Clinically Important Skin Events | Significant skin events (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) occurring during the risk period were identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations. The identification of potential significant skin events was based on algorithms utilizing a combination of diagnoses, procedures and/or medications. Surveillance of outpatient visits was limited to rashes coded as drug-related and requiring use of steroid (e.g. prednisone) administration. Incidence is reported as unadjusted, crude rates. | The analysis includes all eligible participants. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years of followup | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
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| Primary | Incidence of Clinically Important Muscle Events | Significant muscle events (e.g. rhabdomyolysis) occurring during the risk period were identified through the use of computer-stored records of laboratory values, outpatient visits, Emergency Department visits and hospitalizations. The identification of potential significant muscle events was based on algorithms utilizing a combination of diagnoses, procedures and/or laboratory results for creatinine kinase. The number of muscle events did not meet the threshold for statistical analysis per protocol. Incidence is reported as unadjusted, crude rates. | The analysis includes all eligible participants. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years of followup | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
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| Primary | Incidence of Lipodystrophy | Lipodystrophy (e.g. lipoatrophy, facial wasting) occurring during the risk period was identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations. The identification of potential lipodystrophy was based on two coded diagnoses codes indicative of lipodystrophy appearing at least 6 months apart over the course of patient care, the identification of interventions to treat such conditions (e.g. sculptra therapy), or procedural codes for Computerized Tomography indicating incident neck or abdominal lipoaccumulation. Incidence is reported as unadjusted, crude rates. | The analysis includes all eligible participants. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years of followup | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
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| Secondary | Incidence of Clinically Important Cardiovascular Events | Significant cardiovascular events occurring during the risk period were identified through the use of computer-stored records and defined as inpatient events based on algorithms that utilize a combination of diagnosis and/or procedure codes. The identification of potential significant cardiovascular events was based on the occurrence of major adverse cardiovascular events (MACE) which include acute myocardial infarction (MI), ischemic stroke, unstable angina, revascularization (e.g. percutaneous coronary intervention (PCI) and coronary bypass graft surgery (CABG)), and cardiovascular death. Incidence is reported as unadjusted, crude rates. | The analysis includes all eligible participants. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years of followup | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
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| Secondary | Incidence of All-cause Mortality | All-cause mortality occurring during the risk period was identified through the use of computer-stored records of Emergency Department visits, hospitalizations, and state death certificates. Deaths were identified from administrative Kaiser Permanente databases, including Kaiser Permanente regional research and respective state(s) mortality files as well as the Social Security Administrative files. Incidence is reported as unadjusted, crude rates. | The analysis includes all eligible participants. | Posted | Number | 95% Confidence Interval | Events per 1000 person-years of followup | Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013) |
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|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Historical Cohort | Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts. | 0 | 0 | 0 | 0 |
| EG002 | Concurrent Cohort | Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort. | 0 | 0 | 0 | 0 |
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The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status. |
| 0.646 |
| Hazard Ratio (HR) |
| 0.907 |
| 2-Sided |
| 95 |
| 0.597 |
| 1.376 |
| Superiority or Other |
| Poisson Regression | The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status. | 0.182 | Incidence Rate Ratio | 1.268 | 2-Sided | 95 | 0.895 | 1.795 | Superiority or Other |
| Cox Proportional Hazard Regression | The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status. | 0.188 | Hazard Ratio (HR) | 1.257 | 2-Sided | 95 | 0.894 | 1.768 | Superiority or Other |
The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+). |
| 0.070 |
| Hazard Ratio (HR) |
| 1.287 |
| 2-Sided |
| 95 |
| 0.980 |
| 1.690 |
| Superiority or Other |
| Poisson Regression | The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+). | 0.575 | Incidence Rate Ratio | 1.067 | 2-Sided | 95 | 0.850 | 1.339 | Superiority or Other |
| Cox Proportional Hazard Regression | The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+). | 0.626 | Hazard Ratio (HR) | 1.057 | 2-Sided | 95 | 0.847 | 1.319 | Superiority or Other |
The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+). |
| <0.05 |
| Hazard Ratio (HR) |
| 0.471 |
| 2-Sided |
| 95 |
| 0.314 |
| 0.707 |
| Superiority or Other |
| Poisson Regression | The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+). | 0.015 | Incidence Rate Ratio | 1.650 | 2-Sided | 95 | 1.102 | 2.470 | Superiority or Other |
| Cox Proportional Hazard Regression | The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+). | 0.018 | Hazard Ratio (HR) | 1.622 | 2-Sided | 95 | 1.085 | 2.425 | Superiority or Other |
The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+). |
| 0.631 |
| Hazard Ratio (HR) |
| 1.208 |
| 2-Sided |
| 95 |
| 0.559 |
| 2.612 |
| Superiority or Other |
| Poisson Regression | The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+). | 0.592 | Incidence Rate Ratio | 0.845 | 2-Sided | 95 | 0.458 | 1.561 | Superiority or Other |
| Cox Proportional Hazard Regression | The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+). | 0.943 | Hazard Ratio (HR) | 1.022 | 2-Sided | 95 | 0.565 | 1.850 | Superiority or Other |
The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+). |
| 0.356 |
| Hazard Ratio (HR) |
| 0.794 |
| 2-Sided |
| 95 |
| 0.486 |
| 1.296 |
| Superiority or Other |
| Poisson Regression | The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+). | 0.039 | Incidence Rate Ratio | 1.556 | 2-Sided | 95 | 1.022 | 2.370 | Superiority or Other |
| Cox Proportional Hazard Regression | The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+). | 0.033 | Hazard Ratio (HR) | 1.564 | 2-Sided | 95 | 1.036 | 2.361 | Superiority or Other |
| Cox Proportional Hazard Regression | The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 1st treatment regimen. | 0.125 | Hazard Ratio (HR) | 1.720 | 2-Sided | 95 | 0.861 | 3.437 | Superiority or Other |
| Cox Proportional Hazard Regression | The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 2nd treatment regimen. | 0.881 | Hazard Ratio (HR) | 1.056 | 2-Sided | 95 | 0.517 | 2.155 | Superiority or Other |
| Cox Proportional Hazard Regression | The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 3rd+ treatment regimen. | 0.107 | Hazard Ratio (HR) | 2.077 | 2-Sided | 95 | 0.854 | 5.05 | Superiority or Other |