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| ID | Type | Description | Link |
|---|---|---|---|
| 10850 | Other Identifier | DAIDS-ES |
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Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are widely used as part of combination antiretroviral therapy (ART) for infants and children, but NNRTI resistance is increasing, leading to treatment failure. This study tested the safety, tolerability, and dosing levels of etravirine (ETR), a new NNRTI.
Use of NNRTI-based regimens as initial therapy for HIV-infected children is increasing, especially in areas where newborns exposed to HIV-1 receive single-dose nevirapine (NVP) as part of prevention of mother-to-child transmission (PMTCT) regimens and/or daily NVP for prevention of transmission through breastfeeding. First-generation NNRTIs have a low genetic barrier to the development of resistance; in two of the most widely used NNRTIs, NVP and efavirenz (EFV), even a single amino acid mutation in the virus can lead to a reduction in the drug's effectiveness. Even short-term use of these NNRTIs, including only a single dose of NVP, can cause NNRTI resistance. Second-generation NNRTIs are needed as part of ARV regimens for newly diagnosed infants and children who have been exposed to single-dose NVP or who have failed their current antiretroviral (ARV) regimens. In this study, the second-generation NNRTI ETR was tested for safety, tolerability, and appropriate dosing.
Children were assigned to one of three cohorts based on age:
Children in all three cohorts were treatment experienced, defined as being on a failing combination ARV regimen (containing at least 3 ARVs) for at least 8 weeks or having a treatment interruption of at least 4 weeks with a history of virologic failure while on a combination ARV regimen (containing at least 3 ARVs).
Children received ETR together with an optimized background regimen (OBR) consisting of at least 2 active agents (a boosted protease inhibitor [PI] and at least 1 additional active ARV drug). OBR were based on clinical status, treatment history, resistance data, and availability of appropriate pediatric dosing and formulations. The children received an oral dose of ETR twice daily.
Most children had 11 visits: at screening, entry (Day 0), Day 14 (intensive pharmacokinetic [PK] visit), and at Weeks 4, 8, 12, 16, 24, 32, 40, and 48. Most visits included a physical exam, giving a medical history, discussion of adherence, and blood and urine collection. The screening and intensive PK visits also included an electrocardiogram (ECG). During the intensive PK visit, the child had blood drawn approximately 7 times over 12 hours. After the Week 48 visit, children entered the long-term follow-up phase of the study and have a visit every 12 weeks for up to 5 years. These follow-up visits included giving a medical history and undergoing a physical exam and blood draw.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort I: Treatment experienced, 2 to 6 years of age | Experimental | Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug. |
|
| Cohort II: Treatment experienced, 1 to 2 years of age | Experimental | Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. |
|
| Cohort III: Treatment experienced, 2 months to 1 year of age | Experimental | Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etravirine (ETR) | Drug | ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Termination From Treatment Due to a Suspected Adverse Drug Reaction (SADR) | Number (%) of participants who discontinued treatment due to a suspected adverse drug reaction (SADR) by Cohort. | From baseline to occurrence of event, up to Week 48. |
| Adverse Events (AEs) of Grade 3 or Higher Severity | Number (%) of participants who experienced a Grade 3 or higher severity adverse event through Week 48 by Cohort, with Clopper-Pearson confidence intervals. | From baseline to occurrence of event, up to Week 48. |
| Death | Number (%) of deaths on study by Cohort. | From baseline to occurrence of event, up to Week 48. |
| Area Under the Plasma Concentration-Time Curve Over 12 Hours of ETR | Geometric Mean (Standard Deviation) of the area under the plasma concentration-time curve over 12 hours (AUC12h) of ETR. | Pre-dose, 1, 2, 4, 6, 9, and 12 hours post-dose measured at intensive PK visit (within 7-10 days after last dose of study drug administration) |
| Measure | Description | Time Frame |
|---|---|---|
| AEs of Grade 3 or Higher Severity Judged to be at Least Possibly Attributable to the Study Medications | Number (%) of Participants with AEs of Grade 3 or higher severity judged, by the Study Team, to be at least possibly attributable to the study medications by Cohort, including Clopper-Pearson confidence intervals. | From baseline to occurrence of event, up to Week 48. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Rutstein, MD | Children's Hospital of Philadelphia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Perinatal HIV Clinical Trials Unit CRS | Miami | Florida | 33136 | United States | ||
| Lurie Children's Hospital of Chicago (LCH) CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19654564 | Background | Jittamala P, Puthanakit T, Chaiinseeard S, Sirisanthana V. Predictors of virologic failure and genotypic resistance mutation patterns in thai children receiving non-nucleoside reverse transcriptase inhibitor-based antiretroviral therapy. Pediatr Infect Dis J. 2009 Sep;28(9):826-30. doi: 10.1097/INF.0b013e3181a458f9. | |
| 20942667 |
| Label | URL |
|---|---|
| Description DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004; Clarification, August 2009 | View source |
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Participants were stratified into the 3 Cohorts by age group and not randomized. There were no eligibility violations or errors to cohort assignments.
The first participant was enrolled March 2013, and the final participant was enrolled June 2017. Participants were accrued from a total of 11 sites across Brazil, South Africa, and the USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort I: Treatment Experienced, 2 to 6 Years of Age | Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2016 | Jul 16, 2019 |
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|
| HIV-1 RNA Virologic Failure Status at Weeks 24 and 48 | Number (%) of participants with confirmed Virologic Failure, defined as: failure to suppress plasma HIV-1 RNA to fewer than 400 copies/ml and failure to achieve at least a 2-log10 reduction (from baseline) in HIV-1 RNA at Weeks 24 or 48, by Cohort, with Clopper-Pearson confidence intervals. The initial HIV-1 RNA results that met the Virologic Failure definition were each confirmed by a second result obtained within 1 to 4 weeks of the initial result obtained at Week 24 and/or 48. | Baseline, Week 24, and Week 48 |
| Treatment Discontinued Due to Toxicity or Virologic Failure | Number (%) of participants who discontinued study treatment (ETR) due to a toxicity or Virologic Failure (VF), by Cohort. | From baseline to occurrence of event, up to Week 48. |
| Change in Optimized Background Regimen Due to Virologic Failure | Number (%) of participants who initiated a change in their optimized background regimen (OBR) due to virologic failure, by Cohort. | Measured at entry and at Weeks 8, 12, 24, and 48 |
| New Onset Opportunistic Infection (OI) or AIDS Diagnosis | Number (%) of participants with a new onset opportunistic infection (OI) or AIDS diagnosis, by Cohort. | From baseline to occurrence of event, up to Week 48. |
| Decline in Absolute CD4 Percent of Greater Than 5 Percent Any Time After 12 Weeks of Therapy | Number (%) of participants with a >5% decline in absolute CD4 percent from baseline at weeks 12, 24, and 48, by Cohort, including Clopper-Pearson confidence intervals. | Measured at baseline and at Weeks 12, 24, and 48 |
| Chicago |
| Illinois |
| 60614-3393 |
| United States |
| Bronx-Lebanon Hospital Center NICHD CRS | The Bronx | New York | 10457 | United States |
| Jacobi Med. Ctr. Bronx NICHD CRS | The Bronx | New York | 10461 | United States |
| SOM Federal University Minas Gerais Brazil NICHD CRS | Belo Horizonte | Minas Gerais | 30.130-100 | Brazil |
| Hospital Federal dos Servidores do Estado NICHD CRS | Rio de Janeiro | 20221-903 | Brazil |
| Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS | Rio de Janeiro | 21941-612 | Brazil |
| Hosp. Geral De Nova Igaucu Brazil NICHD CRS | Rio de Janeiro | 26030 | Brazil |
| Univ. of Sao Paulo Brazil NICHD CRS | São Paulo | 14049-900 | Brazil |
| Wits RHI Shandukani Research Centre CRS | Johannesburg | Gauteng | 2001 | South Africa |
| Umlazi CRS | Durban | KwaZulu-Natal | 4001 | South Africa |
| Palumbo P, Lindsey JC, Hughes MD, Cotton MF, Bobat R, Meyers T, Bwakura-Dangarembizi M, Chi BH, Musoke P, Kamthunzi P, Schimana W, Purdue L, Eshleman SH, Abrams EJ, Millar L, Petzold E, Mofenson LM, Jean-Philippe P, Violari A. Antiretroviral treatment for children with peripartum nevirapine exposure. N Engl J Med. 2010 Oct 14;363(16):1510-20. doi: 10.1056/NEJMoa1000931. |
| Description Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010 | View source |
| FG001 | Cohort II: Treatment Experienced, 1 to 2 Years of Age | Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
| FG002 | Cohort III: Treatment Experienced, 2 Months to 1 Year of Age | Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Analysis population is defined as having been treated exclusively on the dose determined to be optimal for a given cohort and having either completed 48 weeks of exposure to the study drug or having been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort I: Treatment Experienced, 2 to 6 Years of Age | Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
| BG001 | Cohort II: Treatment Experienced, 1 to 2 Years of Age | Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
| BG002 | Cohort III: Treatment Experienced, 2 Months to 1 Year of Age | Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Plasma HIV RNA | Count of Participants | Participants |
| ||||||||||||||||
| CD4 Count | Count of Participants | Participants |
| ||||||||||||||||
| CD4 Percent | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Termination From Treatment Due to a Suspected Adverse Drug Reaction (SADR) | Number (%) of participants who discontinued treatment due to a suspected adverse drug reaction (SADR) by Cohort. | Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment. | Posted | Count of Participants | Participants | From baseline to occurrence of event, up to Week 48. |
|
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| ||||||||||||||||||||||||||||||||||
| Primary | Adverse Events (AEs) of Grade 3 or Higher Severity | Number (%) of participants who experienced a Grade 3 or higher severity adverse event through Week 48 by Cohort, with Clopper-Pearson confidence intervals. | Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment. | Posted | Count of Participants | Participants | From baseline to occurrence of event, up to Week 48. |
| ||||||||||||||||||||||||||||||||||||
| Primary | Death | Number (%) of deaths on study by Cohort. | Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment. | Posted | Count of Participants | Participants | From baseline to occurrence of event, up to Week 48. |
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| Primary | Area Under the Plasma Concentration-Time Curve Over 12 Hours of ETR | Geometric Mean (Standard Deviation) of the area under the plasma concentration-time curve over 12 hours (AUC12h) of ETR. | Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure. They must also be considered PK evaluable by the study team; 1 Participant in Cohort 1 is not. | Posted | Geometric Mean | Standard Deviation | ng*h/mL | Pre-dose, 1, 2, 4, 6, 9, and 12 hours post-dose measured at intensive PK visit (within 7-10 days after last dose of study drug administration) |
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| Secondary | AEs of Grade 3 or Higher Severity Judged to be at Least Possibly Attributable to the Study Medications | Number (%) of Participants with AEs of Grade 3 or higher severity judged, by the Study Team, to be at least possibly attributable to the study medications by Cohort, including Clopper-Pearson confidence intervals. | Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment. | Posted | Count of Participants | Participants | From baseline to occurrence of event, up to Week 48. |
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| Secondary | HIV-1 RNA Virologic Failure Status at Weeks 24 and 48 | Number (%) of participants with confirmed Virologic Failure, defined as: failure to suppress plasma HIV-1 RNA to fewer than 400 copies/ml and failure to achieve at least a 2-log10 reduction (from baseline) in HIV-1 RNA at Weeks 24 or 48, by Cohort, with Clopper-Pearson confidence intervals. The initial HIV-1 RNA results that met the Virologic Failure definition were each confirmed by a second result obtained within 1 to 4 weeks of the initial result obtained at Week 24 and/or 48. | Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment. | Posted | Count of Participants | Participants | Baseline, Week 24, and Week 48 |
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| Secondary | Treatment Discontinued Due to Toxicity or Virologic Failure | Number (%) of participants who discontinued study treatment (ETR) due to a toxicity or Virologic Failure (VF), by Cohort. | Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment. | Posted | Count of Participants | Participants | From baseline to occurrence of event, up to Week 48. |
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| Secondary | Change in Optimized Background Regimen Due to Virologic Failure | Number (%) of participants who initiated a change in their optimized background regimen (OBR) due to virologic failure, by Cohort. | Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment. | Posted | Count of Participants | Participants | Measured at entry and at Weeks 8, 12, 24, and 48 |
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| Secondary | New Onset Opportunistic Infection (OI) or AIDS Diagnosis | Number (%) of participants with a new onset opportunistic infection (OI) or AIDS diagnosis, by Cohort. | Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment. | Posted | Count of Participants | Participants | From baseline to occurrence of event, up to Week 48. |
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| Secondary | Decline in Absolute CD4 Percent of Greater Than 5 Percent Any Time After 12 Weeks of Therapy | Number (%) of participants with a >5% decline in absolute CD4 percent from baseline at weeks 12, 24, and 48, by Cohort, including Clopper-Pearson confidence intervals. | Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment. | Posted | Count of Participants | Participants | Measured at baseline and at Weeks 12, 24, and 48 |
|
From entry through off study, at an average of 72 weeks.
At entry, all diagnoses, signs/symptoms and laboratory events were collected. Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥Grade 1 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
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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 | Cohort I: Treatment Experienced, 2 to 6 Years of Age | Children in this arm were at least 2 but younger than 6 years of age; they received the study drug etravirine (ETR) together with an optimized background regimen (OBR) consisting of one active boosted protease inhibitor (PI) and at least one other active antiretroviral (ARV) drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. | 0 | 20 | 5 | 20 | 20 | 20 |
| EG001 | Cohort II: Treatment Experienced, 1 to 2 Years of Age | Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. | 0 | 6 | 3 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Splenomegaly | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Keratosis follicular | Congenital, familial and genetic disorders | MedDRA 24.0 | Systematic Assessment |
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| Ear canal erythema | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
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| External ear inflammation | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
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| Otorrhoea | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
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| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA 24.0 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 24.0 | Systematic Assessment |
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| Eyelid disorder | Eye disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Anal pruritus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Lip ulceration | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Oral disorder | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Oral mucosal eruption | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Palatal disorder | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Parotid gland enlargement | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Mucosal discolouration | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Hepatomegaly | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Acarodermatitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Adenoiditis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Body tinea | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Enterobiasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Epstein-Barr virus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Helminthic infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Impetigo | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Latent tuberculosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Lice infestation | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Molluscum contagiosum | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Otitis media acute | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Parasitic gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Parvovirus B19 infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Tinea capitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Tinea faciei | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Tinea manuum | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Toxocariasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Mucosal excoriation | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood pH decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood pH increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood pressure diastolic increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Weight gain poor | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Clubbing | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Motor developmental delay | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Speech disorder developmental | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Breast enlargement | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Penile rash | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nasal pruritus | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tonsillar inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Macule | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
Due to the slow rate of accrual and the challenging accrual into the youngest cohort, enrollment was stopped early.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Allen, Director, IMPAACT Operations Center | Family Health International (FHI 360) | (919) 405-1429 | mallen@fhi360.org |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2019 | Jul 11, 2019 | SAP_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C451734 | etravirine |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Brazil |
|
| South Africa |
|
| 400 - <5,000 copies/ml |
|
| 5,000 - <10,000 copies/ml |
|
| 10,000 - < 25,000 copies/ml |
|
| 25,000 - < 50,000 copies/ml |
|
| >=50,000 copies/ml |
|
| 200 - <350 cells/mm^3 |
|
| 350 - <500 cells/mm^3 |
|
| >=500 cells/mm^3 |
|
| >14 - <25 % |
|
| >= 25 % |
|
| OG002 | Cohort III: Treatment Experienced, 2 Months to 1 Year of Age | Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
|
|
|
| OG002 | Cohort III: Treatment Experienced, 2 Months to 1 Year of Age | Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
|
|
Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.
Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.
|
|
Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug.
Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.
| OG002 | Cohort III: Treatment Experienced, 2 Months to 1 Year of Age | Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
|
|
|
| OG001 |
| Cohort II: Treatment Experienced, 1 to 2 Years of Age |
Children in this arm were at least 1 but younger than 2 years of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
| OG002 | Cohort III: Treatment Experienced, 2 Months to 1 Year of Age | Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
|
|
|
| OG002 | Cohort III: Treatment Experienced, 2 Months to 1 Year of Age | Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
|
|
| OG002 | Cohort III: Treatment Experienced, 2 Months to 1 Year of Age | Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
|
|
| OG002 | Cohort III: Treatment Experienced, 2 Months to 1 Year of Age | Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
|
|
| OG002 | Cohort III: Treatment Experienced, 2 Months to 1 Year of Age | Children in this arm were at least 2 months but younger than 1 year of age; they received ETR together with an OBR consisting of one active boosted PI and at least one other active ARV drug. Etravirine (ETR): ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol. |
|
|
|