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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
All the patients whom an investigator prescribes the first CELSENTRI® Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maraviroc Tablets | Patients administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CELSENTRI® Tablets | Drug | CELSENTRI ® Tablets 150mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Drug Reactions (ADRs) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Number of Participants With Unknown Adverse Drug Reactions (ADRs) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. Unknown ADRs were the ADRs those were not listed on the package insert. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by gender are reported to assess gender as a risk factor for ADR. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by age are reported to assess age as a risk factor for ADR. ">=" refers to greater than or equal to. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies per milliliter (copies/mL). The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion. | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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Inclusion Criteria:
Patients need to be administered CELSENTRI® Tablets in order to be enrolled in the surveillance.
Exclusion Criteria:
Patients not administered CELSENTRI® Tablets.
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The patients whom an investigator involving A4001093 prescribes the Maraviroc Tablets (CELSENTRI® Tablets).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Celsentri (Maraviroc) Tablets | Human immunodeficiency virus (HIV) infected participants, prescribed with Celsentri tablet 150 milligram (mg) depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants those who were registered in this study from April 1, 2009 to March 31, 2017.
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| ID | Title | Description |
|---|---|---|
| BG000 | Celsentri (Maraviroc) Tablets | HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Percentage of Participants With Adverse Drug Reactions (ADRs) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
|
From April 2009 to December 2018 (up to approximately 8 years 8 months)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
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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 | Celsentri (Maraviroc) Tablets | HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glaucoma | Eye disorders | MedDRA v21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2015 | Dec 6, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2018 | Dec 6, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
|
An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by inpatient or outpatient status are reported to assess inpatient or outpatient status as a risk factor for ADR. |
| From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by ethnicity are reported to assess ethnicity as a risk factor for ADR. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Primary: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of History of Therapies for Human Immuno-Deficiency Virus (HIV) Infection | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of history of therapies for HIV Infection are reported to assess presence or absence of history of therapies for HIV Infection as a risk factor for ADR. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by HIV infection duration are reported to assess HIV infection duration as a risk factor for ADR. Unknown: participants for which the duration of HIV infection was not known. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of allergies are reported to assess presence or absence of allergies as a risk factor for ADR. Unknown: participants for which the presence or absence of allergies was not known. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of comorbidities are reported to assess presence or absence of comorbidities as a risk factor for ADR. Comorbidity referred to the presence of co-existing or additional diseases along with HIV infection. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of renal impairment are reported to assess presence or absence of renal impairment as a risk factor for ADR. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of hepatic impairment are reported to assess presence or absence of hepatic impairment as a risk factor for ADR. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of hemophilia are reported to assess presence or absence of hemophilia as a risk factor for ADR. Hemophilia is a bleeding disorder that slows the blood clotting process. Participants with this condition experience prolonged bleeding or oozing following an injury, surgery, or having a tooth pulled. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by mean daily dose of Celsentri are reported to assess mean daily dose of Celsentri as a risk factor for ADR. One tablet of Celsentri had a dose of 150 mg. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by number of concomitant anti-HIV treatment are reported to assess number of concomitant anti-HIV treatment as a risk factor for ADR. Concomitant drugs refers to the drugs other than Celsentri. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification | An ADR:any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by physician.Participants are divided into 3 categories as per CDC classification based on level of HIV infection: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute(primary)HIV-1 infection with accompanying illness or history of acute HIV-1 infection in adult or adolescent aged>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the acquired immunodeficiency syndrome (AIDS) diagnostic criteria, corresponding to conventional AIDS. Unknown: Participants for which CDC classification was not described. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of concomitant therapies are reported to assess presence or absence of concomitant therapies as a risk factor for ADR. Concomitant therapies were the treatments taken by participants to treat comorbid conditions. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of concomitant CYP3A4 enzyme inducer use are reported to assess presence or absence of concomitant CYP3A enzyme inducer use as a risk factor for ADR. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of majority of drugs. Many of the food substances and commonly used drugs act as inducer for enzyme CYP3A4. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by total number of days of administration of Celsentri are reported to assess total number of days of administration of Celsentri as a risk factor for ADR. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by mean total dose of Celsentri are reported to assess mean total dose of Celsentri as a risk factor for ADR. One tablet of Celsentri had a dose of 150 mg. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Immune Function | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Hepatic Function | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Cardiovascular Effects | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | CD4+ Lymphocyte were counted by CD4 cells per cubic millimeter (cells/mm^3). CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
| Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion. | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
| Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
| Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | Participants are divided into 3 categories as per CDC classification based on the level of HIV infection as follows: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute (primary) HIV-1 infection with accompanying illness or history of acute HIV-1 infection in an adult or adolescent aged >=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the acquired immunodeficiency syndrome (AIDS) diagnostic criteria, corresponding to conventional AIDS. Once criteria C has occurred, the person will remain in Category C even if symptoms are alleviated. | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
| Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CD4 cells are the white blood cells and act as a laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. Participants are divided into 3 categories as per CDC classification based on the level of HIV infection as: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute(primary)HIV-1 infection with accompanying illness or history of acute HIV-1 infection in an adult or adolescent aged>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the AIDS diagnostic criteria, corresponding to conventional AIDS. Once criteria C has occurred, the person will remain in Category C even if symptoms are alleviated. | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
| Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion. | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
| Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | CD4 cells are the white blood cells and act as a laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
| Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of majority of drugs. Many of the food substances and commonly used drugs act as inducers of enzyme CYP3A4. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion. | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
| Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of many of drugs. Many of the food substances and commonly used drugs act as inducers of enzyme CYP3A4. | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
| Number of Participants With Tropism Switch From CCR5- to CXCR4-Tropic Variants | CCR5= C-C chemokine receptor type 5 and CXCR4= C-X-C chemokine receptor type 4. Tropism switch is the mutation of CCR5-tropic HIV-1 to a CXCR4-using virus. | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
| Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
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| Primary | Number of Participants With Unknown Adverse Drug Reactions (ADRs) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. Unknown ADRs were the ADRs those were not listed on the package insert. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. | Posted | Count of Participants | Participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by gender are reported to assess gender as a risk factor for ADR. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, number analyzed ('n') signifies participants who were evaluable for this outcome measure as per gender. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by age are reported to assess age as a risk factor for ADR. ">=" refers to greater than or equal to. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per age. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by inpatient or outpatient status are reported to assess inpatient or outpatient status as a risk factor for ADR. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per inpatient or outpatient status. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by ethnicity are reported to assess ethnicity as a risk factor for ADR. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per ethnicity. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Primary: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of History of Therapies for Human Immuno-Deficiency Virus (HIV) Infection | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of history of therapies for HIV Infection are reported to assess presence or absence of history of therapies for HIV Infection as a risk factor for ADR. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of history of therapies for HIV Infection. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by HIV infection duration are reported to assess HIV infection duration as a risk factor for ADR. Unknown: participants for which the duration of HIV infection was not known. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per duration of HIV infection. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of allergies are reported to assess presence or absence of allergies as a risk factor for ADR. Unknown: participants for which the presence or absence of allergies was not known. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of allergies. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of comorbidities are reported to assess presence or absence of comorbidities as a risk factor for ADR. Comorbidity referred to the presence of co-existing or additional diseases along with HIV infection. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of comorbidities. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of renal impairment are reported to assess presence or absence of renal impairment as a risk factor for ADR. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of renal impairment. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of hepatic impairment are reported to assess presence or absence of hepatic impairment as a risk factor for ADR. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of hepatic impairment. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of hemophilia are reported to assess presence or absence of hemophilia as a risk factor for ADR. Hemophilia is a bleeding disorder that slows the blood clotting process. Participants with this condition experience prolonged bleeding or oozing following an injury, surgery, or having a tooth pulled. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of hemophilia. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by mean daily dose of Celsentri are reported to assess mean daily dose of Celsentri as a risk factor for ADR. One tablet of Celsentri had a dose of 150 mg. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per mean daily dose of Celsentri. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by number of concomitant anti-HIV treatment are reported to assess number of concomitant anti-HIV treatment as a risk factor for ADR. Concomitant drugs refers to the drugs other than Celsentri. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per number of concomitant anti-HIV treatments use. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification | An ADR:any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by physician.Participants are divided into 3 categories as per CDC classification based on level of HIV infection: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute(primary)HIV-1 infection with accompanying illness or history of acute HIV-1 infection in adult or adolescent aged>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the acquired immunodeficiency syndrome (AIDS) diagnostic criteria, corresponding to conventional AIDS. Unknown: Participants for which CDC classification was not described. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per CDC classification. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of concomitant therapies are reported to assess presence or absence of concomitant therapies as a risk factor for ADR. Concomitant therapies were the treatments taken by participants to treat comorbid conditions. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of concomitant therapies. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of concomitant CYP3A4 enzyme inducer use are reported to assess presence or absence of concomitant CYP3A enzyme inducer use as a risk factor for ADR. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of majority of drugs. Many of the food substances and commonly used drugs act as inducer for enzyme CYP3A4. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of concomitant CYP3A enzyme inducer use. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by total number of days of administration of Celsentri are reported to assess total number of days of administration of Celsentri as a risk factor for ADR. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per total number of days of administration of Celsentri. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by mean total dose of Celsentri are reported to assess mean total dose of Celsentri as a risk factor for ADR. One tablet of Celsentri had a dose of 150 mg. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per mean total dose of Celsentri. | Posted | Number | percentage of participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Immune Function | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. | Posted | Number | ADRs | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Hepatic Function | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. | The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. | Posted | Number | ADRs | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Primary | Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Cardiovascular Effects | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. | The safety analysis set included all participants who met the criteria for participants and were confirmed to have received at least one dose of Celsentri. | Posted | Number | ADRs | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Secondary | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies per milliliter (copies/mL). The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion. | Efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for individual gender at respective timepoints. | Posted | Mean | Standard Deviation | Log HIV-RNA copies/milliliter(mL) | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| Secondary | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | CD4+ Lymphocyte were counted by CD4 cells per cubic millimeter (cells/mm^3). CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. | Efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom info sirmation about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for individual gender at respective timepoints. | Posted | Mean | Standard Deviation | CD4 cells/mm^3 | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| Secondary | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion. | The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here,'n' signifies participants who were evaluable for this measure for presence or absence of comorbidities at respective timepoints. | Posted | Mean | Standard Deviation | Log HIV-RNA copies/mL | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| Secondary | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. | The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here,'n' signifies participants who were evaluable for this measure for presence or absence of comorbidities at respective timepoints. | Posted | Mean | Standard Deviation | CD4 cells/mm^3 | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| Secondary | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | Participants are divided into 3 categories as per CDC classification based on the level of HIV infection as follows: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute (primary) HIV-1 infection with accompanying illness or history of acute HIV-1 infection in an adult or adolescent aged >=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the acquired immunodeficiency syndrome (AIDS) diagnostic criteria, corresponding to conventional AIDS. Once criteria C has occurred, the person will remain in Category C even if symptoms are alleviated. | The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here,'n' signifies participants who were evaluable for this measure for CDC Classification at respective timepoints. | Posted | Mean | Standard Deviation | Log HIV-RNA copies/mL | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| Secondary | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CD4 cells are the white blood cells and act as a laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. Participants are divided into 3 categories as per CDC classification based on the level of HIV infection as: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute(primary)HIV-1 infection with accompanying illness or history of acute HIV-1 infection in an adult or adolescent aged>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the AIDS diagnostic criteria, corresponding to conventional AIDS. Once criteria C has occurred, the person will remain in Category C even if symptoms are alleviated. | The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for CDC Classification at respective timepoints. | Posted | Mean | Standard Deviation | CD4 cells/mm^3 | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| Secondary | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion. | The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence therapies at respective timepoints. | Posted | Mean | Standard Deviation | Log HIV-RNA copies/mL | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| Secondary | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | CD4 cells are the white blood cells and act as a laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. | The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence therapies at respective timepoints. | Posted | Mean | Standard Deviation | CD4 cells/mm^3 | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| Secondary | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of majority of drugs. Many of the food substances and commonly used drugs act as inducers of enzyme CYP3A4. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion. | The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence of CYP3A4 at respective timepoints. | Posted | Mean | Standard Deviation | Log HIV-RNA copies/mL | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| Secondary | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of many of drugs. Many of the food substances and commonly used drugs act as inducers of enzyme CYP3A4. | The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence of CYP3A4 at respective timepoints. | Posted | Mean | Standard Deviation | CD4 cells/mm^3 | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| Secondary | Number of Participants With Tropism Switch From CCR5- to CXCR4-Tropic Variants | CCR5= C-C chemokine receptor type 5 and CXCR4= C-X-C chemokine receptor type 4. Tropism switch is the mutation of CCR5-tropic HIV-1 to a CXCR4-using virus. | The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From April 2009 to December 2018 (up to approximately 8 years 8 months) |
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| Secondary | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | The efficacy analysis set. Here, "Overall Number of Participants Analyzed" included participants evaluable for this measure. 'n' signifies participants who were evaluable for this measure at specified timepoints. | Posted | Mean | Standard Deviation | Log HIV-RNA copies/mL | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 |
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| 0 |
| 68 |
| 17 |
| 68 |
| 20 |
| 68 |
| Necrotising retinitis | Eye disorders | MedDRA v21.0 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA v21.0 | Systematic Assessment |
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| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
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| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
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| Immune reconstitution inflammatory syndrome | Immune system disorders | MedDRA v21.0 | Systematic Assessment |
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| Aspergillus infection | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
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| Helicobacter infection | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
|
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
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| Syphilis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v21.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
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| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
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| Depressive symptom | Psychiatric disorders | MedDRA v21.0 | Systematic Assessment |
|
| Psychiatric symptom | Psychiatric disorders | MedDRA v21.0 | Systematic Assessment |
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| Calculus urinary | Renal and urinary disorders | MedDRA v21.0 | Systematic Assessment |
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| Prerenal failure | Renal and urinary disorders | MedDRA v21.0 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA v21.0 | Systematic Assessment |
|
| Renal tubular disorder | Renal and urinary disorders | MedDRA v21.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
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| Faeces soft | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v21.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA v21.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v21.0 | Systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | MedDRA v21.0 | Systematic Assessment |
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| Liver disorder | Hepatobiliary disorders | MedDRA v21.0 | Systematic Assessment |
|
| Dermatophytosis of nail | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA v21.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA v21.0 | Systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
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| Hyperphosphatasaemia | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
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| Obesity | Metabolism and nutrition disorders | MedDRA v21.0 | Systematic Assessment |
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| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Systematic Assessment |
|
| Cerebral arteriosclerosis | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v21.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
|
|
| Inpatient and outpatient |
|
|
|
|
|
| >5 years |
|
|
| Unknown |
|
|
|
| Allergies: Unknown |
|
|
|
|
|
|
|
| >2 tablets |
|
|
|
| 3 drugs |
|
|
| >=4 drugs |
|
|
|
| CDC category C |
|
|
| Unknown |
|
|
|
|
|
| > 365 and <=730 days |
|
|
| > 730 and <= 2704 days |
|
|
|
| > 730 and <=1460 tablets |
|
|
| > 1460 and <=21632 tablets |
|
|
|
| Males: Month 6 |
|
|
| Males: Month 9 |
|
|
| Males: Month 12 |
|
|
| Males: Month 15 |
|
|
| Males: Month 18 |
|
|
| Males: Month 21 |
|
|
| Males: Month 24 |
|
|
| Males: Month 27 |
|
|
| Males: Month 30 |
|
|
| Males: Month 33 |
|
|
| Males: Month 36 |
|
|
| Males: Month 39 |
|
|
| Males: Month 42 |
|
|
| Males: Month 45 |
|
|
| Males: Month 48 |
|
|
| Males: Month 51 |
|
|
| Males: Month 54 |
|
|
| Males: Month 57 |
|
|
| Males: Month 60 |
|
|
| Males: Month 63 |
|
|
| Males: Month 66 |
|
| Males: Month 69 |
|
|
| Males: Month 72 |
|
| Males: Month 75 |
|
|
| Males: Month 78 |
|
|
| Males: Month 81 |
|
| Males: Month 84 |
|
|
| Females: Month 0 (Baseline) |
|
|
| Females: Month 3 |
|
|
| Females: Month 6 |
|
| Females: Month 9 |
|
| Females: Month 12 |
|
| Females: Month 15 |
|
|
| Females: Month 18 |
|
| Females: Month 21 |
|
| Females: Month 24 |
|
| Females: Month 27 |
|
| Females: Month 30 |
|
| Females: Month 33 |
|
| Females: Month 36 |
|
| Females: Month 39 |
|
| Females: Month 42 |
|
| Females: Month 45 |
|
| Females: Month 48 |
|
| Females: Month 51 |
|
| Females: Month 54 |
|
| Females: Month 57 |
|
| Females: Month 60 |
|
| Females: Month 63 |
|
| Females: Month 66 |
|
| Females: Month 69 |
|
| Females: Month 72 |
|
| Females: Month 75 |
|
| Females: Month 78 |
|
| Females: Month 81 |
|
| Females: Month 84 |
|
|
| Males: Month 6 |
|
|
| Males: Month 9 |
|
|
| Males: Month 12 |
|
|
| Males: Month 15 |
|
|
| Males: Month 18 |
|
|
| Males: Month 21 |
|
|
| Males: Month 24 |
|
|
| Males: Month 27 |
|
|
| Males: Month 30 |
|
|
| Males: Month 33 |
|
|
| Males: Month 36 |
|
|
| Males: Month 39 |
|
|
| Males: Month 42 |
|
|
| Males: Month 45 |
|
|
| Males: Month 48 |
|
|
| Males: Month 51 |
|
|
| Males: Month 54 |
|
|
| Males: Month 57 |
|
|
| Males: Month 60 |
|
|
| Males: Month 63 |
|
|
| Males: Month 66 |
|
| Males: Month 69 |
|
|
| Males: Month 72 |
|
| Males: Month 75 |
|
|
| Males: Month 78 |
|
|
| Males: Month 81 |
|
| Males: Month 84 |
|
|
| Females: Month 0 (Baseline) |
|
|
| Females: Month 3 |
|
|
| Females: Month 6 |
|
| Females: Month 9 |
|
| Females: Month 12 |
|
| Females: Month 15 |
|
|
| Females: Month 18 |
|
| Females: Month 21 |
|
| Females: Month 24 |
|
| Females: Month 27 |
|
| Females: Month 30 |
|
| Females: Month 33 |
|
| Females: Month 36 |
|
| Females: Month 39 |
|
| Females: Month 42 |
|
| Females: Month 45 |
|
| Females: Month 48 |
|
| Females: Month 51 |
|
| Females: Month 54 |
|
| Females: Month 57 |
|
| Females: Month 60 |
|
| Females: Month 63 |
|
| Females: Month 66 |
|
| Females: Month 69 |
|
| Females: Month 72 |
|
| Females: Month 75 |
|
| Females: Month 78 |
|
| Females: Month 81 |
|
| Females: Month 84 |
|
|
| Comorbidities-Present: Month 6 |
|
|
| Comorbidities-Present: Month 9 |
|
|
| Comorbidities-Present: Month 12 |
|
|
| Comorbidities-Present: Month 15 |
|
|
| Comorbidities-Present: Month 18 |
|
|
| Comorbidities-Present: Month 21 |
|
|
| Comorbidities-Present: Month 24 |
|
|
| Comorbidities-Present: Month 27 |
|
|
| Comorbidities-Present: Month 30 |
|
|
| Comorbidities-Present: Month 33 |
|
|
| Comorbidities-Present: Month 36 |
|
|
| Comorbidities-Present: Month 39 |
|
|
| Comorbidities-Present: Month 42 |
|
|
| Comorbidities-Present: Month 45 |
|
|
| Comorbidities-Present: Month 48 |
|
|
| Comorbidities-Present: Month 51 |
|
|
| Comorbidities-Present: Month 54 |
|
|
| Comorbidities-Present: Month 57 |
|
|
| Comorbidities-Present: Month 60 |
|
|
| Comorbidities-Present: Month 63 |
|
|
| Comorbidities-Present: Month 66 |
|
| Comorbidities-Present: Month 69 |
|
|
| Comorbidities-Present: Month 72 |
|
| Comorbidities-Present: Month 75 |
|
|
| Comorbidities-Present: Month 78 |
|
|
| Comorbidities-Present: Month 81 |
|
| Comorbidities-Present: Month 84 |
|
|
| Comorbidities-Absent: Month 0 (Baseline) |
|
|
| Comorbidities-Absent: Month 3 |
|
|
| Comorbidities-Absent: Month 6 |
|
|
| Comorbidities-Absent: Month 9 |
|
|
| Comorbidities-Absent: Month 12 |
|
|
| Comorbidities-Absent: Month 15 |
|
|
| Comorbidities-Absent: Month 18 |
|
|
| Comorbidities-Absent: Month 21 |
|
|
| Comorbidities-Absent: Month 24 |
|
| Comorbidities-Absent: Month 27 |
|
|
| Comorbidities-Absent: Month 30 |
|
| Comorbidities-Absent: Month 33 |
|
|
| Comorbidities-Absent: Month 36 |
|
|
| Comorbidities-Absent: Month 39 |
|
|
| Comorbidities-Absent: Month 42 |
|
|
| Comorbidities-Absent: Month 45 |
|
|
| Comorbidities-Absent: Month 48 |
|
|
| Comorbidities-Absent: Month 51 |
|
|
| Comorbidities-Absent: Month 54 |
|
| Comorbidities-Absent: Month 57 |
|
|
| Comorbidities-Absent: Month 60 |
|
| Comorbidities-Absent: Month 63 |
|
|
| Comorbidities-Absent: Month 66 |
|
| Comorbidities-Absent: Month 69 |
|
|
| Comorbidities-Absent: Month 72 |
|
| Comorbidities-Absent: Month 75 |
|
| Comorbidities-Absent: Month 78 |
|
| Comorbidities-Absent: Month 81 |
|
| Comorbidities-Absent: Month 84 |
|
|
| Comorbidities-Present: Month 6 |
|
|
| Comorbidities-Present: Month 9 |
|
|
| Comorbidities-Present: Month 12 |
|
|
| Comorbidities-Present: Month 15 |
|
|
| Comorbidities-Present: Month 18 |
|
|
| Comorbidities-Present: Month 21 |
|
|
| Comorbidities-Present: Month 24 |
|
|
| Comorbidities-Present: Month 27 |
|
|
| Comorbidities-Present: Month 30 |
|
|
| Comorbidities-Present: Month 33 |
|
|
| Comorbidities-Present: Month 36 |
|
|
| Comorbidities-Present: Month 39 |
|
|
| Comorbidities-Present: Month 42 |
|
|
| Comorbidities-Present: Month 45 |
|
|
| Comorbidities-Present: Month 48 |
|
|
| Comorbidities-Present: Month 51 |
|
|
| Comorbidities-Present: Month 54 |
|
|
| Comorbidities-Present: Month 57 |
|
|
| Comorbidities-Present: Month 60 |
|
|
| Comorbidities-Present: Month 63 |
|
|
| Comorbidities-Present: Month 66 |
|
| Comorbidities-Present: Month 69 |
|
|
| Comorbidities-Present: Month 72 |
|
| Comorbidities-Present: Month 75 |
|
|
| Comorbidities-Present: Month 78 |
|
|
| Comorbidities-Present: Month 81 |
|
| Comorbidities-Present: Month 84 |
|
|
| Comorbidities-Absent: Month 0 (Baseline) |
|
|
| Comorbidities-Absent: Month 3 |
|
|
| Comorbidities-Absent: Month 6 |
|
|
| Comorbidities-Absent: Month 9 |
|
|
| Comorbidities-Absent: Month 12 |
|
|
| Comorbidities-Absent: Month 15 |
|
|
| Comorbidities-Absent: Month 18 |
|
|
| Comorbidities-Absent: Month 21 |
|
|
| Comorbidities-Absent: Month 24 |
|
| Comorbidities-Absent: Month 27 |
|
|
| Comorbidities-Absent: Month 30 |
|
| Comorbidities-Absent: Month 33 |
|
|
| Comorbidities-Absent: Month 36 |
|
|
| Comorbidities-Absent: Month 39 |
|
|
| Comorbidities-Absent: Month 42 |
|
|
| Comorbidities-Absent: Month 45 |
|
|
| Comorbidities-Absent: Month 48 |
|
|
| Comorbidities-Absent: Month 51 |
|
|
| Comorbidities-Absent: Month 54 |
|
| Comorbidities-Absent: Month 57 |
|
|
| Comorbidities-Absent: Month 60 |
|
| Comorbidities-Absent: Month 63 |
|
|
| Comorbidities-Absent: Month 66 |
|
| Comorbidities -Absent: Month 69 |
|
|
| Comorbidities-Absent: Month 72 |
|
| Comorbidities-Absent: Month 75 |
|
| Comorbidities-Absent: Month 78 |
|
| Comorbidities-Absent: Month 81 |
|
| Comorbidities-Absent: Month 84 |
|
|
| CDC category A: Month 6 |
|
|
| CDC category A: Month 9 |
|
|
| CDC category A: Month 12 |
|
|
| CDC category A: Month 15 |
|
|
| CDC category A: Month 18 |
|
|
| CDC category A: Month 21 |
|
|
| CDC category A: Month 24 |
|
|
| CDC category A: Month 27 |
|
|
| CDC category A: Month 30 |
|
| CDC category A: Month 33 |
|
|
| CDC category A: Month 36 |
|
|
| CDC category A: Month 39 |
|
|
| CDC category A: Month 42 |
|
|
| CDC category A: Month 45 |
|
|
| CDC category A: Month 48 |
|
|
| CDC category A: Month 51 |
|
|
| CDC category A: Month 54 |
|
| CDC category A: Month 57 |
|
|
| CDC category A: Month 60 |
|
| CDC category A: Month 63 |
|
|
| CDC category A: Month 66 |
|
| CDC category A: Month 69 |
|
|
| CDC category A: Month 72 |
|
| CDC category A: Month 75 |
|
|
| CDC category A: Month 78 |
|
|
| CDC category A: Month 81 |
|
| CDC category A: Month 84 |
|
|
| CDC category B: Month 0 (Baseline) |
|
|
| CDC category B: Month 3 |
|
|
| CDC category B: Month 6 |
|
|
| CDC category B: Month 9 |
|
| CDC category B: Month 12 |
|
| CDC category B: Month 15 |
|
|
| CDC category B: Month 18 |
|
|
| CDC category B: Month 21 |
|
| CDC category B: Month 24 |
|
|
| CDC category B: Month 27 |
|
|
| CDC category B: Month 30 |
|
|
| CDC category B: Month 33 |
|
|
| CDC category B: Month 36 |
|
| CDC category B: Month 39 |
|
|
| CDC category B: Month 42 |
|
|
| CDC category B: Month 45 |
|
|
| CDC category B: Month 48 |
|
|
| CDC category B: Month 51 |
|
|
| CDC category B: Month 54 |
|
| CDC category B: Month 57 |
|
| CDC category B: Month 60 |
|
|
| CDC category B: Month 63 |
|
|
| CDC category B: Month 66 |
|
| CDC category B: Month 69 |
|
| CDC category B: Month 72 |
|
| CDC category B: Month 75 |
|
| CDC category B: Month 78 |
|
| CDC category B: Month 81 |
|
| CDC category B: Month 84 |
|
| CDC category C: Month 0 (Baseline) |
|
|
| CDC category C: Month 3 |
|
|
| CDC category C: Month 6 |
|
|
| CDC category C: Month 9 |
|
|
| CDC category C: Month 12 |
|
|
| CDC category C: Month 15 |
|
|
| CDC category C: Month 18 |
|
|
| CDC category C: Month 21 |
|
|
| CDC category C: Month 24 |
|
|
| CDC category C: Month 27 |
|
|
| CDC category C: Month 30 |
|
|
| CDC category C: Month 33 |
|
|
| CDC category C: Month 36 |
|
|
| CDC category C: Month 39 |
|
|
| CDC category C: Month 42 |
|
|
| CDC category C: Month 45 |
|
| CDC category C: Month 48 |
|
| CDC category C: Month 51 |
|
|
| CDC category C: Month 54 |
|
|
| CDC category C: Month 57 |
|
|
| CDC category C: Month 60 |
|
|
| CDC category C: Month 63 |
|
| CDC category C: Month 66 |
|
| CDC category C: Month 69 |
|
|
| CDC category C: Month 72 |
|
| CDC category C: Month 75 |
|
| CDC category C: Month 78 |
|
| CDC category C: Month 81 |
|
| CDC category C: Month 84 |
|
|
| CDC category A: Month 6 |
|
|
| CDC category A: Month 9 |
|
|
| CDC category A: Month 12 |
|
|
| CDC category A: Month 15 |
|
|
| CDC category A: Month 18 |
|
|
| CDC category A: Month 21 |
|
|
| CDC category A: Month 24 |
|
|
| CDC category A: Month 27 |
|
|
| CDC category A: Month 30 |
|
| CDC category Month 33 |
|
|
| CDC category A: Month 36 |
|
|
| CDC category A: Month 39 |
|
|
| CDC category A: Month 42 |
|
|
| CDC category A: Month 45 |
|
|
| CDC category A: Month 48 |
|
|
| CDC category A: Month 51 |
|
|
| CDC category A: Month 54 |
|
| CDC category A: Month 57 |
|
|
| CDC category A: Month 60 |
|
| CDC category A: Month 63 |
|
|
| CDC category A: Month 66 |
|
| CDC category A: Month 69 |
|
|
| CDC category A: Month 72 |
|
| CDC category A: Month 75 |
|
|
| CDC category A: Month 78 |
|
|
| CDC category A: Month 81 |
|
| CDC category A : Month 84 |
|
|
| CDC category B: Month 0 (Baseline) |
|
|
| CDC category B: Month 3 |
|
|
| CDC category B: Month 6 |
|
|
| CDC category B: Month 9 |
|
| CDC category B: Month 12 |
|
| CDC category B: Month 15 |
|
|
| CDC category B: Month 18 |
|
|
| CDC category B: Month 21 |
|
| CDC category B: Month 24 |
|
|
| CDC category B: Month 27 |
|
|
| CDC category B: Month 30 |
|
|
| CDC category B: Month 33 |
|
|
| CDC category B: Month 36 |
|
| CDC category B: Month 39 |
|
|
| CDC category B: Month 42 |
|
|
| CDC category B: Month 45 |
|
|
| CDC category B: Month 48 |
|
|
| CDC category B: Month 51 |
|
|
| CDC category B: Month 54 |
|
| CDC category B: Month 57 |
|
| CDC category B: Month 60 |
|
|
| CDC category B: Month 63 |
|
|
| CDC category B: Month 66 |
|
| CDC category B: Month 69 |
|
| CDC category B: Month 72 |
|
| CDC category B: Month 75 |
|
| CDC category B: Month 78 |
|
| CDC category B: Month 81 |
|
| CDC category B: Month 84 |
|
| CDC category C: Month 0 (Baseline) |
|
|
| CDC category C: Month 3 |
|
|
| CDC category C: Month 6 |
|
|
| CDC category C: Month 9 |
|
|
| CDC category C: Month 12 |
|
|
| CDC category C: Month 15 |
|
|
| CDC category C: Month 18 |
|
|
| CDC category C: Month 21 |
|
|
| CDC category C: Month 24 |
|
|
| CDC category C: Month 27 |
|
|
| CDC category C: Month 30 |
|
|
| CDC category C: Month 33 |
|
|
| CDC category C: Month 36 |
|
|
| CDC category C: Month 39 |
|
|
| CDC category C: Month 42 |
|
|
| CDC category C: Month 45 |
|
| CDC category C: Month 48 |
|
| CDC category C: Month 51 |
|
|
| CDC category C: Month 54 |
|
|
| CDC category C: Month 57 |
|
|
| CDC category C: Month 60 |
|
|
| CDC category C: Month 63 |
|
| CDC category C: Month 66 |
|
| CDC category C: Month 69 |
|
|
| CDC category C: Month 72 |
|
| CDC category C: Month 75 |
|
| CDC category C: Month 78 |
|
| CDC category C: Month 81 |
|
| CDC category C: Month 84 |
|
|
| Present: Month 6 |
|
|
| Present: Month 9 |
|
|
| Present: Month 12 |
|
|
| Present: Month 15 |
|
|
| Present: Month 18 |
|
|
| Present: Month 21 |
|
|
| Present: Month 24 |
|
|
| Present: Month 27 |
|
|
| Present: Month 30 |
|
|
| Present: Month 33 |
|
|
| Present: Month 36 |
|
|
| Present: Month 39 |
|
|
| Present: Month 42 |
|
|
| Present: Month 45 |
|
|
| Present: Month 48 |
|
|
| Present: Month 51 |
|
|
| Present: Month 54 |
|
|
| Present: Month 57 |
|
|
| Present: Month 60 |
|
|
| Present: Month 63 |
|
|
| Present: Month 66 |
|
| Present: Month 69 |
|
|
| Present: Month 72 |
|
| Present: Month 75 |
|
|
| Present: Month 78 |
|
|
| Present: Month 81 |
|
| Present: Month 84 |
|
|
| Absent: Month 0 (Baseline) |
|
|
| Absent: Month 3 |
|
|
| Absent: Month 6 |
|
|
| Absent: Month 9 |
|
|
| Absent: Month 12 |
|
|
| Absent: Month 15 |
|
|
| Absent: Month 18 |
|
| Absent: Month 21 |
|
|
| Absent: Month 24 |
|
|
| Absent: Month 27 |
|
|
| Absent: Month 30 |
|
| Absent: Month 33 |
|
|
| Absent: Month 36 |
|
|
| Absent: Month 39 |
|
|
| Absent: Month 42 |
|
|
| Absent: Month 45 |
|
| Absent: Month 48 |
|
| Absent: Month 51 |
|
| Absent: Month 54 |
|
| Absent: Month 57 |
|
| Absent: Month 60 |
|
| Absent: Month 63 |
|
| Absent: Month 66 |
|
| Absent: Month 69 |
|
| Absent: Month 72 |
|
| Absent: Month 75 |
|
| Absent: Month 78 |
|
| Absent: Month 81 |
|
| Absent: Month 84 |
|
|
| Present: Month 6 |
|
|
| Present: Month 9 |
|
|
| Present: Month 12 |
|
|
| Present: Month 15 |
|
|
| Present: Month 18 |
|
|
| Present: Month 21 |
|
|
| Present: Month 24 |
|
|
| Present: Month 27 |
|
|
| Present: Month 30 |
|
|
| Present: Month 33 |
|
|
| Present: Month 36 |
|
|
| Present: Month 39 |
|
|
| Present: Month 42 |
|
|
| Present: Month 45 |
|
|
| Present: Month 48 |
|
|
| Present: Month 51 |
|
|
| Present: Month 54 |
|
|
| Present: Month 57 |
|
|
| Present: Month 60 |
|
|
| Present: Month 63 |
|
|
| Present: Month 66 |
|
| Present: Month 69 |
|
|
| Present: Month 72 |
|
| Present: Month 75 |
|
|
| Present: Month 78 |
|
|
| Present: Month 81 |
|
| Present: Month 84 |
|
|
| Absent: Month 0 |
|
|
| Absent: Month 3 |
|
|
| Absent: Month 6 |
|
|
| Absent: Month 9 |
|
|
| Absent: Month 12 |
|
|
| Absent: Month 15 |
|
|
| Absent: Month 18 |
|
| Absent: Month 21 |
|
|
| Absent: Month 24 |
|
|
| Absent: Month 27 |
|
|
| Absent: Month 30 |
|
| Absent: Month 33 |
|
|
| Absent: Month 36 |
|
|
| Absent: Month 39 |
|
|
| Absent: Month 42 |
|
|
| Absent: Month 45 |
|
| Absent: Month 48 |
|
| Absent: Month 51 |
|
| Absent: Month 54 |
|
| Absent: Month 57 |
|
| Absent: Month 60 |
|
| Absent: Month 63 |
|
| Absent: Month 66 |
|
| Absent: Month 69 |
|
| Absent: Month 72 |
|
| Absent: Month 75 |
|
| Absent: Month 78 |
|
| Absent: Month 81 |
|
| Absent: Month 84 |
|
|
| Present: Month 6 |
|
|
| Present: Month 9 |
|
|
| Present: Month 12 |
|
|
| Present: Month 15 |
|
|
| Present: Month 18 |
|
|
| Present: Month 21 |
|
|
| Present: Month 24 |
|
|
| Present: Month 27 |
|
| Present: Month 30 |
|
| Present: Month 33 |
|
|
| Present: Month 36 |
|
|
| Present: Month 39 |
|
|
| Present: Month 42 |
|
|
| Present: Month 45 |
|
|
| Present: Month 48 |
|
|
| Present: Month 51 |
|
|
| Present: Month 54 |
|
| Present: Month 57 |
|
|
| Present: Month 60 |
|
| Present: Month 63 |
|
|
| Present: Month 66 |
|
| Present: Month 69 |
|
|
| Present: Month 72 |
|
| Present: Month 75 |
|
|
| Present: Month 78 |
|
|
| Present: Month 81 |
|
| Present: Month 84 |
|
|
| Absent: Month 0 (Baseline) |
|
|
| Absent: Month 3 |
|
|
| Absent: Month 6 |
|
|
| Absent: Month 9 |
|
|
| Absent: Month 12 |
|
|
| Absent: Month 15 |
|
|
| Absent: Month 18 |
|
|
| Absent: Month 21 |
|
|
| Absent: Month 24 |
|
|
| Absent: Month 27 |
|
|
| Absent: Month 30 |
|
|
| Absent: Month 33 |
|
|
| Absent: Month 36 |
|
|
| Absent: Month 39 |
|
|
| Absent: Month 42 |
|
|
| Absent: Month 45 |
|
|
| Absent: Month 48 |
|
|
| Absent: Month 51 |
|
|
| Absent: Month 54 |
|
|
| Absent: Month 57 |
|
|
| Absent: Month 60 |
|
|
| Absent: Month 63 |
|
|
| Absent: Month 66 |
|
| Absent: Month 69 |
|
|
| Absent: Month 72 |
|
| Absent: Month 75 |
|
| Absent: Month 78 |
|
| Absent: Month 81 |
|
| Absent: Month 84 |
|
|
| Present: Month 6 |
|
|
| Present: Month 9 |
|
|
| Present: Month 12 |
|
|
| Present: Month 15 |
|
|
| Present: Month 18 |
|
|
| Present: Month 21 |
|
|
| Present: Month 24 |
|
|
| Present: Month 27 |
|
| Present: Month 30 |
|
| Present: Month 33 |
|
|
| Present: Month 36 |
|
|
| Present: Month 39 |
|
|
| Present: Month 42 |
|
|
| Present: Month 45 |
|
|
| Present: Month 48 |
|
|
| Present: Month 51 |
|
|
| Present: Month 54 |
|
| Present: Month 57 |
|
|
| Present: Month 60 |
|
| Present: Month 63 |
|
|
| Present: Month 66 |
|
| Present: Month 69 |
|
|
| Present: Month 72 |
|
| Present: Month 75 |
|
|
| Present: Month 78 |
|
|
| Present: Month 81 |
|
| Present: Month 84 |
|
|
| Absent: Month 0 (Baseline) |
|
|
| Absent: Month 3 |
|
|
| Absent: Month 6 |
|
|
| Absent: Month 9 |
|
|
| Absent: Month 12 |
|
|
| Absent: Month 15 |
|
|
| Absent: Month 18 |
|
|
| Absent: Month 21 |
|
|
| Absent: Month 24 |
|
|
| Absent: Month 27 |
|
|
| Absent: Month 30 |
|
|
| Absent: Month 33 |
|
|
| Absent: Month 36 |
|
|
| Absent: Month 39 |
|
|
| Absent: Month 42 |
|
|
| Absent: Month 45 |
|
|
| Absent: Month 48 |
|
|
| Absent: Month 51 |
|
|
| Absent: Month 54 |
|
|
| Absent: Month 57 |
|
|
| Absent: Month 60 |
|
|
| Absent: Month 63 |
|
|
| Absent: Month 66 |
|
| Absent: Month 69 |
|
|
| Absent: Month 72 |
|
| Absent: Month 75 |
|
| Absent: Month 78 |
|
| Absent: Month 81 |
|
| Absent: Month 84 |
|
|
| At Month 6 |
|
|
| At Month 9 |
|
|
| At Month 12 |
|
|
| At Month 15 |
|
|
| At Month 18 |
|
|
| At Month 21 |
|
|
| At Month 24 |
|
|
| At Month 27 |
|
|
| At Month 30 |
|
|
| At Month 33 |
|
|
| At Month 36 |
|
|
| At Month 39 |
|
|
| At Month 42 |
|
|
| At Month 45 |
|
|
| At Month 48 |
|
|
| At Month 51 |
|
|
| At Month 54 |
|
|
| At Month 57 |
|
|
| At Month 60 |
|
|
| At Month 63 |
|
|
| At Month 66 |
|
| At Month 69 |
|
|
| At Month 72 |
|
| At Month 75 |
|
|
| At Month 78 |
|
|
| At Month 81 |
|
| At Month 84 |
|
|