Safety of and Immune Response to Dolutegravir in HIV-1 In... | NCT01302847 | Trialant
NCT01302847
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Status
Completed
Last Update Posted
Dec 12, 2024Actual
Enrollment
181Actual
Phase
Phase 1Phase 2
Conditions
HIV Infections
Interventions
DTG film-coated tablets
DTG granules for suspension
DTG dispersible tablets
DTG dispersible tablets
DTG dispersible tablets
Countries
United States
Botswana
Brazil
Kenya
South Africa
Tanzania
Thailand
Zimbabwe
Protocol Section
Identification Module
NCT ID
NCT01302847
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P1093
Secondary IDs
ID
Type
Description
Link
11773
Registry Identifier
DAIDS-ES
2010-020988-20
EudraCT Number
IMPAACT P1093
Brief Title
Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents
Official Title
Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents
Acronym
Not provided
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 20, 2011Actual
Primary Completion Date
Jan 20, 2021Actual
Completion Date
Oct 18, 2023Actual
First Submitted Date
Feb 15, 2011
First Submission Date that Met QC Criteria
Feb 22, 2011
First Posted Date
Feb 24, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 11, 2022
Results First Submitted that Met QC Criteria
Feb 23, 2022
Results First Posted Date
Mar 22, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 9, 2024
Last Update Posted Date
Dec 12, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study evaluated the pharmacokinetics (PK), safety, tolerability of and immune response to DTG when used concurrently with optimized background therapy (OBT) in HIV-1 infected infants, children, and adolescents.
Detailed Description
DTG is an HIV medicine in the integrase inhibitor drug class. The purpose of this study was to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of DTG when used concurrently with OBT in HIV-1 infected infants, children, and adolescents.
Participants in this study were evaluated for PK, safety and tolerability through 48 weeks, followed by additional long-term study follow-up that lasted for approximately 144 weeks (3 years), for a total of 192 weeks on study. This study had two stages. Stage I provided pharmacokinetics, short-term tolerability and safety data on DTG on a limited number of participants to permit dose selection for further study in Stage II. Once a Stage I dose was accepted, enrollment to Stage II began to complete enrollment to the cohort. Stage II provided longer-term safety and antiviral activity data among a larger number of participants.
Infants, children and adolescents with HIV-1, aged ≥ 4 weeks to < 18 years enrolled in the age and formulation cohorts specified below:
Cohort I: Adolescents ≥ 12 to <18 years of age (film-coated tablets)
Cohort IIA: Children ≥ 6 to <12 years of age (film-coated tablets)
Cohort IIB: Children ≥ 6 to <12 years of age (granules for suspension)
Cohort III: Children ≥ 2 to < 6 years of age (granules for suspension)
Cohort IV: Children ≥ 6 months to < 2 years of age (granules for suspension)
Cohort III-DT: Children ≥ 2 to < 6 years of age (dispersible tablets)
Cohort IV-DT: Children ≥ 6 months to < 2 years of age (dispersible tablets)
Cohorts were opened sequentially according by age group (starting with the older age group), DTG formulation, and study stage, i.e. Initial study enrollment was for Cohort I and progressed to Cohort IIA once Cohort I Stage I met the PK and safety criteria, followed by opening of Cohort IIB. Each cohort enrolled in two sequential stages: Stage I and II (the only exception is Cohort IIB, which only enrolled through Stage I). Sequential enrollment for Cohort III and IV proceeded in the same manner. Cohort V never enrolled because of the recommended changes in dosing and inclusion of enrollment weight band in the criteria for dose finding.
Stage I participants had physical examinations and had blood draws for safety assessments at study visits: Day 0; Day 5 (+5 days); and Weeks 4, 8, 12, 16, 24, 32, 40, and 48. Stage I participants also had intensive PK sampling with blood samples collected at time 0 (pre-dose), and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing. Once a Stage I treatment dose was accepted, enrollment to Stage II began to complete enrollment to the cohort. Stage II participants had physical examinations and blood draws for safety assessment at study visits: Day 0; Day 10; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48. Blood, plasma, and urine were collected and tested to measure immune response. Females of childbearing potential underwent pregnancy testing at screening and at every study visit.
After 48 weeks, all Stage I and Stage II participants entered the long-term study follow-up and continued to receive DTG. During this time, participants had safety and/or antiviral activity assessments every 12 weeks for up to 3 years.
The study was able to determine a proposed dose (i.e. optimal dose) for Cohorts I, IIA, III-DT, IV-DT, and V-DT but not for Cohorts IIB, III, and IV. Participants on the proposed dose had intensive PK sampling between days 5 and10 of DTG initiation with blood samples collected at time 0 (pre-dose), and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing.
The study is closed to accrual and study follow-up was completed on Oct 18, 2023.
Conditions Module
Conditions
HIV Infections
Keywords
Integrase Inhibitors
Infant
Child
Adolescent
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
181Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort I
Experimental
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets
Drug: DTG film-coated tablets
Cohort IIA
Experimental
Children 6 to younger than 12 years of age who received DTG film-coated tablets
Drug: DTG film-coated tablets
Cohort IIB
Experimental
Children 6 to younger than 12 years of age who received DTG granules for suspension
Drug: DTG granules for suspension
Cohort III
Experimental
Children 2 to younger than 6 years of age who received DTG granules for suspension
Drug: DTG granules for suspension
Cohort IV
Experimental
Children 6 months to younger than 2 years of age who received DTG granules for suspension
Drug: DTG granules for suspension
Cohort III-DT
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
DTG film-coated tablets
Drug
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily. Participants weighing ≥ 35kg received the proposed dose of 50 mg of DTG film-coated tablets.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)
All grade 3 or higher signs/symptoms, diagnoses, and laboratory AEs were included.
AE grading was based on DAIDS AE Grading Table, Version 1.0, December 2004 (Clarification, August 2009).
A 2-sided 95% Confidence Interval (CI) was calculated for the percentage using the binominal exact method.
From treatment initiation through Weeks 24 and 48
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug
All grade 3 or higher signs/symptoms, diagnoses, and laboratory AEs were included.
AE grading was based on DAIDS AE Grading Table, Version 1.0, December 2004 (Clarification, August 2009).
A 2-sided 95% Confidence Interval (CI) was calculated for the percentage using the binominal exact method.
From treatment initiation through Weeks 24 and 48
Number of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events (AEs) Assessed as Related to Study Drug
Number of participants with permanent discontinuation of study drug due to AEs assessed by the site investigator as related to the study drug.
From treatment initiation through Weeks 24 and 48
Number of Participants Who Died
Number of participants who died were summarized
From treatment initiation through Weeks 24 and 48
PK Parameter: Area-under-the-curve From 0 to 24 Hours (AUC0-24)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). AUC0-24 was determined using linear up-log down estimation in WinNonlin.
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)
Percentage and exact 95% Confidence Interval (CI) of participants with Grade 3 or higher AEs. AEs were graded based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009 (see References). All grade 3 or higher signs, symptoms, and laboratory toxicities were included.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Confirmed HIV-1 infection, defined as positive results from two samples collected at different time points (see protocol for more information)
Participant belonged to one of the ARV exposure groups below:
ARV-treatment experienced (not including receipt of ARVs as prophylaxis or for prevention of perinatal transmission)
Previously took ARVs for treatment, but not taking ARVs at study screening.
Had been off treatment for greater than or equal to 4 weeks prior to screening, OR
At screening, taking ARVs for treatment but failing.
Was on an unchanged, failing therapeutic regimen within the 4 to 12 weeks prior to screening (less than or equal to 1 log drop in HIV-1 RNA within the 4 to 12 weeks prior to screening). OR
For participants less than 2 years of age, initiated ARVs for treatment less than 4 weeks prior to screening.
ARV treatment naive (no exposure to ARVs for treatment; could have received ARVs for prophylaxis or prevention of perinatal transmission)
If an infant had received nevirapine (NVP) as prophylaxis to prevent perinatal transmission, he or she did not receive NVP for at least 14 days prior to enrollment into Stage I or II.
HIV-1 RNA viral load greater than 1,000 copies/mL of plasma at screening.
Demonstrated ability or willingness to swallow assigned study medications.
Parent or legal guardian were able and willing to provide signed informed consent.
Female participants of reproductive potential, defined as having reached menarche, and who were engaging in sexual activity that could lead to pregnancy, agreed to use two contraceptive methods while on study and for two weeks after stopping study drug.
Males engaging in sexual activity that could lead to HIV-1 transmission agreed to use a condom.
Agreed to stay on optimized background therapy (OBT) while on study:
Participants who at screening were greater than or equal to 2 years of age and ARV-treatment experienced, had at screening at least one fully active drug for the OBT.
Participants who were greater than or equal to 2 years of age and ARV-treatment naïve, had genotype testing at screening/entry even with results pending.
Participants less than 2 years of age (either ARV-treatment experienced or ARV treatment naïve), had genotype testing at screening/entry even with results pending.
Exclusion Criteria:
Presence of any active AIDS-defining opportunistic infection
At enrollment, participant less than 3.0 kg
Known Grade 3 or greater of any of the following laboratory toxicities within 30 days prior to study entry: neutrophil count, hemoglobin, platelets, aspartate aminotransferase (AST), alanine transaminase (ALT), lipase, serum creatinine and total bilirubin. A single repeat within the 30 days is allowed for eligibility determination. NOTE: Grade 3 total bilirubin was allowable, if the participant was on atazanavir (ATV).
ANY known Grade 4 laboratory toxicities within 30 days prior to study entry. NOTE: Grade 4 total bilirubin was allowable, if the participant was on ATV.
The following liver toxicities within 30 days prior to study entry: ALT greater than 3x the upper limit of normal (ULN) AND direct bilirubin was greater than 2x ULN
Any prior history of malignancy, with the exception of localized malignancies such as squamous cell or basal cell carcinoma of the skin
Clinical or symptomatic evidence of pancreatitis, as determined by the clinician
Use of any disallowed medications at time of screening (see the protocol for a complete list of disallowed medications)
Known history of exposure to integrase inhibitor treatment by the participant or participant's mother prior to delivery/cessation of breastfeeding
Known resistance to an integrase inhibitor
Women who were pregnant or breastfeeding
At screening/entry, participating in or had participated in a study with a compound or device that was not commercially available within 30 days of signing informed consent, unless permission from both Protocol Teams was granted
Participant was unlikely to adhere to the study procedures, keep appointments, or was planning to relocate during the study to a non-IMPAACT study site
Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study
At screening/entry had used, or anticipated using, chronic systemic immunosuppressive agents or systemic interferon (e.g., for treatment of hepatitis C virus [HCV] infection) within 30 days prior to beginning DTG study treatment. Systemic corticosteroids (e.g., prednisone or equivalent up to 2 mg/kg/day) for replacement therapy or short courses (less than or equal to 30 days) were permitted. (See protocol for more information on disallowed medications.)
Any condition that in the opinion of the site investigator, placed the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.
Active tuberculosis (TB) disease and/or requirement for treatment that included rifampin at the time of the screening visit. However, participants who needed rifampin treatment while on DTG were allowed to continue in P1093 provided the DTG dose was adjusted according to the protocol.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
4 Weeks
Maximum Age
17 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Andrew Wiznia, M.D.
Jacobi Medical Center
Study Chair
Theodore Ruel, M.D.
University of California, San Francisco
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program (Site ID: 4601)
Bennetto-Hood C, Tabolt G, Savina P, Acosta EP. A sensitive HPLC-MS/MS method for the determination of dolutegravir in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Jan 15;945-946:225-32. doi: 10.1016/j.jchromb.2013.11.054. Epub 2013 Dec 3.
Viani RM, Alvero C, Fenton T, Acosta EP, Hazra R, Townley E, Steimers D, Min S, Wiznia A; P1093 Study Team. Safety, Pharmacokinetics and Efficacy of Dolutegravir in Treatment-experienced HIV-1 Infected Adolescents: Forty-eight-week Results from IMPAACT P1093. Pediatr Infect Dis J. 2015 Nov;34(11):1207-13. doi: 10.1097/INF.0000000000000848.
See Also Links
Label
URL
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009).
There was no study randomization. A participant was enrolled to a cohort based on their age at study entry.
Recruitment Details
Participants were enrolled from April 20, 2011 to February 19, 2020. Participants were recruited from 9 countries in North America, South America, Africa, and Asia.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
FG001
Cohort IIA
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol: Protocol V5.0
Jul 12, 2018
Jan 11, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Puerto Rico
Uganda
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Children 2 to younger than 6 years of age who received DTG dispersible tablets
Drug: DTG dispersible tablets
Cohort IV-DT
Experimental
Children 6 months to younger than 2 years of age who received DTG dispersible tablets
Drug: DTG dispersible tablets
Cohort V-DT
Experimental
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets
Drug: DTG dispersible tablets
Cohort I
Cohort IIA
DTG granules for suspension
Drug
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
Cohort IIB
Cohort III
Cohort IV
DTG dispersible tablets
Drug
DTG dispersible tablets initial starting dose of ~0.8 mg/kg with a maximum dose of 30 mg; orally once daily. The proposed weight-band dosing was:
Weight band 3 to <6 kg: 5 mg DTG dispersible tablets; Weight band 6 to <10 kg: 15 mg DTG dispersible tablets; Weight band 10 to <14 kg: 20 mg DTG dispersible tablets; Weight band 14 to <20 kg: 25 mg DTG dispersible tablets; Weight band ≥20 kg: 30 mg DTG dispersible tablets.
Cohort III-DT
DTG dispersible tablets
Drug
DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily. The proposed weight-band dosing was:
Weight band 3 to <6 kg: 5 mg DTG dispersible tablets; Weight band 6 to <10 kg: 15 mg DTG dispersible tablets; Weight band 10 to <14 kg: 20 mg DTG dispersible tablets; Weight band 14 to <20 kg: 25 mg DTG dispersible tablets; Weight band ≥20 kg: 30 mg DTG dispersible tablets.
Cohort IV-DT
DTG dispersible tablets
Drug
DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily. The proposed weight-band dosing was:
Weight band 3 to <6 kg: 5 mg DTG dispersible tablets; Weight band 6 to <10 kg: 15 mg DTG dispersible tablets.
Cohort V-DT
From treatment initiation through Week 192. AEs after that time were censored.
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug
Percentage and exact 95% Confidence Interval (CI) of participants with Grade 3 or higher AEs assessed by the site investigator as related to the study drug.
From treatment initiation through Week 192. AEs after that time were censored.
Number of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events (AEs) Assessed as Related to Study Drug
Number of participants with permanent discontinuation of study drug due to AEs assessed by the site investigator as related to the study drug.
From treatment initiation through Week 192. AEs after that time were censored.
Number of Participants Who Died
Number of participants who died were summarized.
From treatment initiation through Week 192. AEs after that time were censored.
Percentage of Participants With Plasma HIV-1 RNA Less Than 400 Copies/ml
Virologic responses were assessed at weeks 24 and 48 as percentages of participants and exact 95% Confidence Interval (CI). The virologic response or virologic failure was defined and calculated according to FDA's Snapshot algorithm.
Week 24 and Week 48
Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/ml
Virologic responses were assessed at weeks 24 and 48 as percentages of participants and exact 95% Confidence Interval (CI), The virologic response or virologic failure was defined and calculated according to FDA's Snapshot algorithm.
Week 24 and Week 48
PK Parameter: Plasma Concentration Observed at End of 24 Hour Dosing Interval (C24h)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). C24h was taken directly from the observed concentration-time data or estimated using the elimination rate constant.
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
PK Parameter: Plasma Concentration Observed Immediately to Dosing of 24 Hour Dosing Interval (C0h)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). C0h was taken directly from the observed concentration-time data.
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
PK Parameter: Minimum Plasma Concentration (Cmin)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ) and were performed in real-time. Cmin was taken directly from the observed concentration-time data.
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
PK Parameter: Maximum Plasma Concentration (Cmax)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). Cmax was taken directly from the observed concentration-time data.
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
PK Parameter: Apparent Clearance (CL/F)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). CL/F was calculated as Dose/AUC.
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
PK Parameter: Apparent Volume of Distribution (Vz/F)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). Vz/F was calculated as Dose/(ke x AUC).
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
PK Parameter: Terminal Half-life (t1/2)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). t1/2 was calculated as ln(2)/ke.
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
Summary of Changes in CD4 Count From Baseline
The median differences between CD4 count at Week 24 and 48 minus at the Day 0 (baseline), and Interquartile Ranges (IQRs) are presented.
Measured at Day 0, Week 24, and Week 48
Summary of Changes in CD4 Percent From Baseline
The median differences between CD4 percent at Week 24 and 48 minus at the Day 0 (baseline), and Interquartile Ranges (IQRs) are presented.
Measured at Day 0, Week 24, and Week 48
Summary of Changes in CD8 Count From Baseline
The median differences between CD8 count at Week 24 and 48 minus at the Day 0 (baseline), and Interquartile Ranges (IQRs) are presented.
Measured at Day 0, Week 24, and Week 48
Summary of Changes in CD8 Percent From Baseline
The median differences between CD8 percent at Week 24 and 48 minus at the Day 0 (baseline), and Interquartile Ranges (IQRs) are presented.
Measured at Day 0, Week 24, and Week 48
Genotypic Measures of Resistance to Integrase
Genes were sequenced and compared to a reference sequence to identify mutations
At baseline
Genotypic Measures of Resistance to Integrase
Genes were sequenced and compared to a reference sequence to identify mutations
at virological failure visit at or prior to Week 192
Genotypic Measures of Resistance to Protease
Genes were sequenced and compared to a reference sequence to identify mutations
at baseline
Genotypic Measures of Resistance to Protease
Genes were sequenced and compared to a reference sequence to identify mutations
at virological failures at or prior to Week 192
Genotypic Measures of Resistance to Reverse Transcriptase
Genes were sequenced and compared to a reference sequence to identify mutations
at baseline
Genotypic Measures of Resistance to Reverse Transcriptase
Genes were sequenced and compared to a reference sequence to identify mutations
at virologic failure at or prior to Week 192
Phenotypic Measures of Resistance
The participant viral culture is considered to be reduced susceptibility if more DTG is needed to inactivate 50% of the participant viral culture compared to the control viral specimen
Whenever virological failures took place from baseline to week 192
Worst Case CDC HIV Classification Status
Disease progression as measured by change from baseline to the worst case CDC HIV classification status
From baseline through Week 192
Miller Children's Hosp. Long Beach CA NICHD CRS (Site ID: 5093)
Long Beach
California
90806
United States
David Geffen School of Medicine at UCLA NICHD CRS (Site ID: 5112)
Los Angeles
California
90095-1752
United States
Univ. of California San Francisco NICHD CRS (Site ID: 5091)
San Francisco
California
94143
United States
Univ. of Colorado Denver NICHD CRS (Site ID: 5052)
Aurora
Colorado
80045
United States
Howard Univ. Washington DC NICHD CRS (Site ID: 5044)
Washington D.C.
District of Columbia
20060
United States
South Florida CDTC Ft Lauderdale NICHD CRS (Site ID: 5055)
Fort Lauderdale
Florida
33316
United States
USF - Tampa NICHD CRS (Site ID: 5018)
Tampa
Florida
33606
United States
Rush Univ. Cook County Hosp. Chicago NICHD CRS (Site ID: 5083)
Chicago
Illinois
60612
United States
Lurie Children's Hospital of Chicago (LCH) CRS (Site ID: 4001)
Chicago
Illinois
60614-3393
United States
Children's Hosp. of Boston NICHD CRS (Site ID: 5009)
Boston
Massachusetts
02115
United States
Boston Medical Center Ped. HIV Program NICHD CRS (Site ID: 5011)
Boston
Massachusetts
02118
United States
Metropolitan Hosp. NICHD CRS (Site ID: 5003)
New York
New York
10029
United States
Bronx-Lebanon Hospital Center NICHD CRS (Site ID: 5114)
The Bronx
New York
10457
United States
Jacobi Med. Ctr. Bronx NICHD CRS (Site ID: 5013)
The Bronx
New York
10461
United States
DUMC Ped. CRS (Site ID: 4701)
Durham
North Carolina
27710
United States
Seattle Children's Research Institute CRS (Site ID: 5017)
Seattle
Washington
98101
United States
Gaborone CRS (Site ID: 12701)
Gaborone
South-East District
Botswana
Molepolole CRS (Site ID: 12702)
Gaborone
Botswana
SOM Federal University Minas Gerais Brazil NICHD CRS (Site ID: 5073)
Belo Horizonte
Minas Gerais
30.130-100
Brazil
Hospital Federal dos Servidores do Estado NICHD CRS (Site ID: 5072)
Rio de Janeiro
20221-903
Brazil
Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS (Site ID: 5071)
Rio de Janeiro
21941-612
Brazil
Hosp. Geral De Nova Igaucu Brazil NICHD CRS (Site ID: 5097)
Rio de Janeiro
26030
Brazil
Univ. of Sao Paulo Brazil NICHD CRS (Site ID: 5074)
São Paulo
14049-900
Brazil
Kenya Medical Research Institute / Walter Reed Project Clinical Research Center, Kericho CRS (Site ID: 5121)
Kericho
20200
Kenya
Wits RHI Shandukani Research Centre CRS (Site ID: 8051)
Johannesburg
Gauteng
2001
South Africa
Umlazi CRS (Site ID: 30300)
Durban
KwaZulu-Natal
4001
South Africa
FAMCRU CRS (Site ID: 8950)
Tygerberg
Western Cape
7505
South Africa
Kilimanjaro Christian Medical Centre (KCMC) (Site ID: 5118)
Moshi
Tanzania
Siriraj Hospital, Mahidol University NICHD CRS (Site ID: 5115)
Viani RM, Ruel T, Alvero C, Fenton T, Acosta EP, Hazra R, Townley E, Palumbo P, Buchanan AM, Vavro C, Singh R, Graham B, Anthony P, George K, Wiznia A; P1093 Study Team. Long-Term Safety and Efficacy of Dolutegravir in Treatment-Experienced Adolescents With Human Immunodeficiency Virus Infection: Results of the IMPAACT P1093 Study. J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):159-165. doi: 10.1093/jpids/piy139.
Singh RP, Adkison KK, Baker M, Parasrampuria R, Wolstenholme A, Davies M, Sewell N, Brothers C, Buchanan AM. Development of Dolutegravir Single-entity and Fixed-dose Combination Formulations for Children. Pediatr Infect Dis J. 2022 Mar 1;41(3):230-237. doi: 10.1097/INF.0000000000003366.
Vavro C, Ruel T, Wiznia A, Montanez N, Nangle K, Horton J, Buchanan AM, Stewart EL, Palumbo P. Emergence of Resistance in HIV-1 Integrase with Dolutegravir Treatment in a Pediatric Population from the IMPAACT P1093 Study. Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0164521. doi: 10.1128/AAC.01645-21. Epub 2021 Oct 25.
Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
FG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
FG003
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
FG004
Cohort IV
Children 6 months to younger than 2 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
FG005
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of ~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
FG006
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
FG007
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
FG00023 subjects
FG00123 subjects
FG00215 subjects
FG00317 subjects
FG0047 subjects
FG00536 subjects
FG00635 subjects
FG00725 subjects
COMPLETED
FG00010 subjects
FG00116 subjects
FG00214 subjects
FG00315 subjects
FG0045 subjects
FG00531 subjects
FG00630 subjects
FG00720 subjects
NOT COMPLETED
FG00013 subjects
FG0017 subjects
FG0021 subjects
FG0032 subjects
FG0042 subjects
FG0055 subjects
FG0065 subjects
FG0075 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
Pregnancy
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Virologic failure
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG004
Severe debilitation, unable to continue
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Not able to get to clinic
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Site closing
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Not willing to adhere to requirements
FG0005 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Site unable to contact participant
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Participants who received at least one dose of DTG.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
BG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
BG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
BG003
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
BG004
Cohort IV
Children 6 months to younger than 2 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
BG005
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of ~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
BG006
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
BG007
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00023
BG00123
BG00215
BG00317
BG0047
BG00536
BG00635
BG00725
BG008181
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG00215
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
Height
Mean
Standard Deviation
cm
Title
Denominators
Categories
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
CD4 Cell Count
Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
Median
Inter-Quartile Range
cells/mm^3
Title
Denominators
Categories
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
CD4 Percent
Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
Median
Inter-Quartile Range
Percentage of total lymphocytes
Title
Denominators
Categories
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
CD8 Cell Count
Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
Median
Inter-Quartile Range
cells/mm^3
Title
Denominators
Categories
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
CD8 Percent
Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
Median
Inter-Quartile Range
Percentage of total lymphocytes
Title
Denominators
Categories
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
Baseline Plasma HIV-1 RNA (copies/mL)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
HIV-1 log10 RNA
Mean
Standard Deviation
log10 copies/mL
Title
Denominators
Categories
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
Class of Prior Antiretroviral Therapy (ART)
Note: These categories are not mutually exclusive since some participants would have received multiple ARTs.
Count of Participants
Participants
Title
Denominators
Categories
Nucleoside reverse transcriptase inhibitor (NRTI)
ParticipantsBG00023
ParticipantsBG00123
ParticipantsBG002
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 Grade 3 or Higher Adverse Events (AEs)
All grade 3 or higher signs/symptoms, diagnoses, and laboratory AEs were included.
AE grading was based on DAIDS AE Grading Table, Version 1.0, December 2004 (Clarification, August 2009).
A 2-sided 95% Confidence Interval (CI) was calculated for the percentage using the binominal exact method.
Participants who received at least one dose of DTG and were deemed safety evaluable by the protocol team.
Posted
Number
95% Confidence Interval
percentage of participants
From treatment initiation through Weeks 24 and 48
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
OG003
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
OG004
Cohort IV
Children 6 months to younger than 2 years of age who received DTG granules for suspension
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
OG005
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of ~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
OG006
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
OG007
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
Units
Counts
Participants
OG00023
OG00123
OG00215
OG003
Title
Denominators
Categories
Through Week 24
Title
Measurements
OG0004.3(0.1 to 22.0)
OG0018.7(1.1 to 28.0)
OG0026.7(0.2 to 32.0)
OG003
Primary
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug
All grade 3 or higher signs/symptoms, diagnoses, and laboratory AEs were included.
AE grading was based on DAIDS AE Grading Table, Version 1.0, December 2004 (Clarification, August 2009).
A 2-sided 95% Confidence Interval (CI) was calculated for the percentage using the binominal exact method.
Participants who received at least one dose of DTG and were deemed safety evaluable by the protocol team.
Posted
Number
95% Confidence Interval
percentage of participants
From treatment initiation through Weeks 24 and 48
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
Primary
Number of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events (AEs) Assessed as Related to Study Drug
Number of participants with permanent discontinuation of study drug due to AEs assessed by the site investigator as related to the study drug.
Participants who received at least one dose of DTG and were deemed safety evaluable by the protocol team.
Posted
Count of Participants
Participants
From treatment initiation through Weeks 24 and 48
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
Primary
Number of Participants Who Died
Number of participants who died were summarized
Participants who received at least one dose of DTG and were deemed safety evaluable by the protocol team.
Posted
Count of Participants
Participants
From treatment initiation through Weeks 24 and 48
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
OG003
Cohort III
Primary
PK Parameter: Area-under-the-curve From 0 to 24 Hours (AUC0-24)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). AUC0-24 was determined using linear up-log down estimation in WinNonlin.
Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Posted
Mean
Standard Deviation
hr*mg/L
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG002
Cohort III-DT
Children 2 to younger than 6 years of age who received weight band dosing at ~1 mg/kg of DTG dispersible tablet orally once daily.
Secondary
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)
Percentage and exact 95% Confidence Interval (CI) of participants with Grade 3 or higher AEs. AEs were graded based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009 (see References). All grade 3 or higher signs, symptoms, and laboratory toxicities were included.
All participants
Posted
Number
95% Confidence Interval
percentage of participants
From treatment initiation through Week 192. AEs after that time were censored.
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
Secondary
Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug
Percentage and exact 95% Confidence Interval (CI) of participants with Grade 3 or higher AEs assessed by the site investigator as related to the study drug.
All participants
Posted
Number
95% Confidence Interval
percentage of participants
From treatment initiation through Week 192. AEs after that time were censored.
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
OG003
Secondary
Number of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events (AEs) Assessed as Related to Study Drug
Number of participants with permanent discontinuation of study drug due to AEs assessed by the site investigator as related to the study drug.
All participants
Posted
Count of Participants
Participants
From treatment initiation through Week 192. AEs after that time were censored.
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
OG003
Secondary
Number of Participants Who Died
Number of participants who died were summarized.
All participants
Posted
Count of Participants
Participants
From treatment initiation through Week 192. AEs after that time were censored.
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
OG003
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
Secondary
Percentage of Participants With Plasma HIV-1 RNA Less Than 400 Copies/ml
Virologic responses were assessed at weeks 24 and 48 as percentages of participants and exact 95% Confidence Interval (CI). The virologic response or virologic failure was defined and calculated according to FDA's Snapshot algorithm.
Participants who received at least one dose of DTG.
Posted
Number
95% Confidence Interval
percentage of participants
Week 24 and Week 48
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
Secondary
Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/ml
Virologic responses were assessed at weeks 24 and 48 as percentages of participants and exact 95% Confidence Interval (CI), The virologic response or virologic failure was defined and calculated according to FDA's Snapshot algorithm.
Participants who received at least one dose of DTG.
Posted
Number
95% Confidence Interval
percentage of participants
Week 24 and Week 48
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
Secondary
PK Parameter: Plasma Concentration Observed at End of 24 Hour Dosing Interval (C24h)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). C24h was taken directly from the observed concentration-time data or estimated using the elimination rate constant.
Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Posted
Mean
Standard Deviation
ng/mL
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG002
Cohort III-DT
Children 2 to younger than 6 years of age who received weight band dosing at ~1 mg/kg of DTG dispersible tablet orally once daily.
Secondary
PK Parameter: Plasma Concentration Observed Immediately to Dosing of 24 Hour Dosing Interval (C0h)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). C0h was taken directly from the observed concentration-time data.
Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Posted
Mean
Standard Deviation
ng/mL
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG002
Cohort III-DT
Children 2 to younger than 6 years of age who received weight band dosing at ~1 mg/kg of DTG dispersible tablet orally once daily.
Secondary
PK Parameter: Minimum Plasma Concentration (Cmin)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ) and were performed in real-time. Cmin was taken directly from the observed concentration-time data.
Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Posted
Mean
Standard Deviation
ng/mL
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG002
Cohort III-DT
Children 2 to younger than 6 years of age who received weight band dosing at ~1 mg/kg of DTG dispersible tablet orally once daily.
Secondary
PK Parameter: Maximum Plasma Concentration (Cmax)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). Cmax was taken directly from the observed concentration-time data.
Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Posted
Mean
Standard Deviation
ng/mL
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG002
Cohort III-DT
Children 2 to younger than 6 years of age who received weight band dosing at ~1 mg/kg of DTG dispersible tablet orally once daily.
OG003
Secondary
PK Parameter: Apparent Clearance (CL/F)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). CL/F was calculated as Dose/AUC.
Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Posted
Mean
Standard Deviation
L/h
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG002
Cohort III-DT
Children 2 to younger than 6 years of age who received weight band dosing at ~1 mg/kg of DTG dispersible tablet orally once daily.
OG003
Cohort IV-DT
Secondary
PK Parameter: Apparent Volume of Distribution (Vz/F)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). Vz/F was calculated as Dose/(ke x AUC).
Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Posted
Mean
Standard Deviation
L
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG002
Cohort III-DT
Children 2 to younger than 6 years of age who received weight band dosing at ~1 mg/kg of DTG dispersible tablet orally once daily.
OG003
Secondary
PK Parameter: Terminal Half-life (t1/2)
Determined from plasma concentration-time profiles using non-compartmental methods (Phoenix WinNonlin 8.0 or current, Certara, Princeton, NJ). t1/2 was calculated as ln(2)/ke.
Participants with intensive pharmacokinetic (PK) data at the proposed dose for Cohorts I, IIA, III-DT, IV-DT, and V-DT.
Posted
Mean
Standard Deviation
h
One intensive PK visit between 5 and 10 days of DTG initiation. At intensive PK visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received 50 mg DTG film-coated tablets orally once daily for those weighing ≥ 35kg.
OG002
Cohort III-DT
Children 2 to younger than 6 years of age who received weight band dosing at ~1 mg/kg of DTG dispersible tablet orally once daily.
OG003
Cohort IV-DT
Secondary
Summary of Changes in CD4 Count From Baseline
The median differences between CD4 count at Week 24 and 48 minus at the Day 0 (baseline), and Interquartile Ranges (IQRs) are presented.
Participants who received at least one dose of DTG. Study participants who had non-missing values were summarized.
Posted
Median
Inter-Quartile Range
cells/mm^3
Measured at Day 0, Week 24, and Week 48
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
OG003
Secondary
Summary of Changes in CD4 Percent From Baseline
The median differences between CD4 percent at Week 24 and 48 minus at the Day 0 (baseline), and Interquartile Ranges (IQRs) are presented.
Participants who received at least one dose of DTG. Study participants who had non-missing values were summarized.
Posted
Median
Inter-Quartile Range
Percentage of total lymphocytes
Measured at Day 0, Week 24, and Week 48
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
OG003
Secondary
Summary of Changes in CD8 Count From Baseline
The median differences between CD8 count at Week 24 and 48 minus at the Day 0 (baseline), and Interquartile Ranges (IQRs) are presented.
Participants who received at least one dose of DTG. Study participants who had non-missing values were summarized.
Posted
Median
Inter-Quartile Range
cells/mm^3
Measured at Day 0, Week 24, and Week 48
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
OG003
Secondary
Summary of Changes in CD8 Percent From Baseline
The median differences between CD8 percent at Week 24 and 48 minus at the Day 0 (baseline), and Interquartile Ranges (IQRs) are presented.
Participants who received at least one dose of DTG. Study participants who had non-missing values were summarized.
Posted
Median
Inter-Quartile Range
Percentage of total lymphocytes
Measured at Day 0, Week 24, and Week 48
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
OG003
Secondary
Genotypic Measures of Resistance to Integrase
Genes were sequenced and compared to a reference sequence to identify mutations
All participants with a confirmed decrease in HIV RNA of < 1.0 log10 at or after week 12 unless the HIV RNA is < 400 copies/mL, or a confirmed HIV RNA > 400 copies/mL starting at Week 24 or beyond on 2 consecutive measurements at least 1 week and within 4 weeks apart
Posted
Count of Participants
Participants
At baseline
ID
Title
Description
OG000
All VF Participants
All participants with virological failure
Units
Counts
Participants
OG000
Secondary
Genotypic Measures of Resistance to Integrase
Genes were sequenced and compared to a reference sequence to identify mutations
All participants with a confirmed decrease in HIV RNA of < 1.0 log10 at or after week 12 unless the HIV RNA is < 400 copies/mL, or a confirmed HIV RNA > 400 copies/mL starting at Week 24 or beyond on 2 consecutive measurements at least 1 week and within 4 weeks apart
Posted
Count of Participants
Participants
at virological failure visit at or prior to Week 192
ID
Title
Description
OG000
All VF Participants
All participants with virological failure
Units
Counts
Participants
OG000
Secondary
Genotypic Measures of Resistance to Protease
Genes were sequenced and compared to a reference sequence to identify mutations
all participants with a confirmed decrease in HIV RNA of < 1.0 log10 at or after week 12 unless the HIV RNA is < 400 copies/mL, or a confirmed HIV RNA > 400 copies/mL starting at Week 24 or beyond on 2 consecutive measurements at least 1 week and within 4 weeks apart
Posted
Count of Participants
Participants
at baseline
ID
Title
Description
OG000
All VF Participants
All participants with virological failure
Units
Counts
Participants
OG000
Secondary
Genotypic Measures of Resistance to Protease
Genes were sequenced and compared to a reference sequence to identify mutations
all participants with a confirmed decrease in HIV RNA of < 1.0 log10 at or after week 12 unless the HIV RNA is < 400 copies/mL, or a confirmed HIV RNA > 400 copies/mL starting at Week 24 or beyond on 2 consecutive measurements at least 1 week and within 4 weeks apart
Posted
Count of Participants
Participants
at virological failures at or prior to Week 192
ID
Title
Description
OG000
All VF Participants
All participants with virological failure
Units
Counts
Participants
OG000
Secondary
Genotypic Measures of Resistance to Reverse Transcriptase
Genes were sequenced and compared to a reference sequence to identify mutations
all participants with a confirmed decrease in HIV RNA of < 1.0 log10 at or after week 12 unless the HIV RNA is < 400 copies/mL, or a confirmed HIV RNA > 400 copies/mL starting at Week 24 or beyond on 2 consecutive measurements at least 1 week and within 4 weeks apart
Posted
Count of Participants
Participants
at baseline
ID
Title
Description
OG000
All VF Participants
All participants with virological failure
Units
Counts
Participants
OG000
Secondary
Genotypic Measures of Resistance to Reverse Transcriptase
Genes were sequenced and compared to a reference sequence to identify mutations
all participants with a confirmed decrease in HIV RNA of < 1.0 log10 at or after week 12 unless the HIV RNA is < 400 copies/mL, or a confirmed HIV RNA > 400 copies/mL starting at Week 24 or beyond on 2 consecutive measurements at least 1 week and within 4 weeks apart
Posted
Count of Participants
Participants
at virologic failure at or prior to Week 192
ID
Title
Description
OG000
All VF Participants
All participants with virological failure
Units
Counts
Participants
OG000
Secondary
Phenotypic Measures of Resistance
The participant viral culture is considered to be reduced susceptibility if more DTG is needed to inactivate 50% of the participant viral culture compared to the control viral specimen
Protocol defined virological failure population for which drug susceptibility was measured
Posted
Count of Participants
Participants
Whenever virological failures took place from baseline to week 192
ID
Title
Description
OG000
Cohort I
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
OG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
OG003
Secondary
Worst Case CDC HIV Classification Status
Disease progression as measured by change from baseline to the worst case CDC HIV classification status
All participants enrolled into the study
Posted
Count of Participants
Participants
From baseline through Week 192
ID
Title
Description
OG000
Not Symptomatic
The worst-case CDC HIV classification status was not symptomatic (<13 years of age)
OG001
Mildly Symptomatic
The worst-case CDC HIV classification status is mildly symptomatic (<13 years of age)
OG002
Moderately Symptomatic
The worst-case CDC HIV classification status was moderately symptomatic (<13 years of age)
OG003
Severely Symptomatic
The worst-case CDC HIV classification status was severely symptomatic (<13 years of age)
OG004
Stage III
Time Frame
From study entry to completion of follow-up by Week 192 or longer, for participants on long-term follow-up. Five, 4, 3, 1 and 1 participants completed visit week 216, 228, 240, 278 and 284, respectively; all follow-up was included.
Description
AEs were summarized for participants who received at least one dose of Dolutegravir (DTG). AE severity grading was based on the DAIDS AE Grading Table, Version 1.0. SAEs were reported according to DAIDS EAE Manual V2.0.
All-Cause Mortality Comment
Not provided
Arm/Groups
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
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
0
23
8
23
23
23
EG001
Cohort IIA
Children 6 to younger than 12 years of age who received DTG film-coated tablets.
DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily.
1
23
5
23
23
23
EG002
Cohort IIB
Children 6 to younger than 12 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
0
15
1
15
15
15
EG003
Cohort III
Children 2 to younger than 6 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
0
17
8
17
17
17
EG004
Cohort IV
Children 6 months to younger than 2 years of age who received DTG granules for suspension.
DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily.
0
7
2
7
7
7
EG005
Cohort III-DT
Children 2 to younger than 6 years of age who received DTG dispersible tablets. DTG dispersible tables initial starting dose of ~0.8 mg/kg with a maximum dose of 30 mg; orally once daily.
1
36
12
36
36
36
EG006
Cohort IV-DT
Children 6 months to younger than 2 years of age who received DTG dispersible tablets.
DTG dispersible tables initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
1
35
8
35
35
35
EG007
Cohort V-DT
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets.
DTG dispersible tables initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Retinoblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 26.1
Systematic Assessment
EG0003 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Abnormal behaviour
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Acquired hydrocele
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG0030 affected17 at risk
EG0041 affected7 at risk
EG0052 affected36 at risk
EG0062 affected35 at risk
EG0073 affected25 at risk
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0007 affected23 at risk
EG0017 affected23 at risk
EG0023 affected15 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Craniosynostosis
Congenital, familial and genetic disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0014 affected23 at risk
EG0022 affected15 at risk
EG003
Noninfective myringitis
Ear and labyrinth disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0013 affected23 at risk
EG0021 affected15 at risk
EG003
Tympanic membrane disorder
Ear and labyrinth disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Tympanic membrane hyperaemia
Ear and labyrinth disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Tympanic membrane perforation
Ear and labyrinth disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0013 affected23 at risk
EG0021 affected15 at risk
EG003
Blepharitis
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Chalazion
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Conjunctival pallor
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Eye discharge
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Eye movement disorder
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Eye opacity
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Eye pain
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0011 affected23 at risk
EG0022 affected15 at risk
EG003
Pterygium
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Scleritis
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0007 affected23 at risk
EG0011 affected23 at risk
EG0022 affected15 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0004 affected23 at risk
EG0013 affected23 at risk
EG0021 affected15 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Anal erythema
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Anal pruritus
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0008 affected23 at risk
EG0016 affected23 at risk
EG0022 affected15 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Gingival ulceration
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Infantile vomiting
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Lip pain
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Lip ulceration
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0008 affected23 at risk
EG0011 affected23 at risk
EG0022 affected15 at risk
EG003
Noninfective gingivitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Oral mucosal eruption
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Oral mucosal erythema
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0006 affected23 at risk
EG0014 affected23 at risk
EG0026 affected15 at risk
EG003
Chest discomfort
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Chest pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Fatigue
General disorders
MedDRA 26.1
Systematic Assessment
EG0003 affected23 at risk
EG0012 affected23 at risk
EG0021 affected15 at risk
EG003
Feeling hot
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Influenza like illness
General disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Malaise
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0022 affected15 at risk
EG003
Medical device site pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Peripheral swelling
General disorders
MedDRA 26.1
Systematic Assessment
EG0003 affected23 at risk
EG0012 affected23 at risk
EG0021 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA 26.1
Systematic Assessment
EG0008 affected23 at risk
EG0017 affected23 at risk
EG0025 affected15 at risk
EG003
Ulcer
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Immune reconstitution inflammatory syndrome
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0022 affected15 at risk
EG003
Adenoiditis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Anal candidiasis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Ascariasis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Balanitis candida
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Body tinea
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0022 affected15 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0012 affected23 at risk
EG0022 affected15 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0012 affected23 at risk
EG0021 affected15 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Enterobiasis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Giardiasis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
HIV-associated neurocognitive disorder
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Helminthic infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Herpangina
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Impetigo
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0013 affected23 at risk
EG0021 affected15 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Lice infestation
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Measles
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG003
Otitis media
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG003
Otitis media chronic
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0022 affected15 at risk
EG003
Parasitic gastroenteritis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0003 affected23 at risk
EG0012 affected23 at risk
EG0023 affected15 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0013 affected23 at risk
EG0021 affected15 at risk
EG003
Pustule
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0012 affected23 at risk
EG0021 affected15 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Schistosomiasis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Septic rash
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Sinusitis bacterial
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Tinea capitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0014 affected23 at risk
EG0020 affected15 at risk
EG003
Tinea faciei
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Tinea infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0022 affected15 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Upper respiratory tract infection bacterial
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Varicella
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Viral infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Adverse event following immunisation
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Scar
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0012 affected23 at risk
EG0022 affected15 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Skin wound
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0005 affected23 at risk
EG0018 affected23 at risk
EG0024 affected15 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0005 affected23 at risk
EG0017 affected23 at risk
EG0023 affected15 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0003 affected23 at risk
EG0014 affected23 at risk
EG0022 affected15 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0015 affected23 at risk
EG0024 affected15 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG00011 affected23 at risk
EG00110 affected23 at risk
EG0026 affected15 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0005 affected23 at risk
EG0016 affected23 at risk
EG0023 affected15 at risk
EG003
Blood calcium decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Blood calcium increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0012 affected23 at risk
EG0021 affected15 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Blood glucose decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0008 affected23 at risk
EG00112 affected23 at risk
EG0027 affected15 at risk
EG003
Blood glucose increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0014 affected23 at risk
EG0022 affected15 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0003 affected23 at risk
EG0012 affected23 at risk
EG0022 affected15 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0004 affected23 at risk
EG0012 affected23 at risk
EG0021 affected15 at risk
EG003
Blood potassium increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Blood pressure diastolic increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Blood pressure increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Blood pressure systolic increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0006 affected23 at risk
EG0018 affected23 at risk
EG0029 affected15 at risk
EG003
Blood sodium increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG003
Blood urine present
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Cardiac murmur
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0016 affected23 at risk
EG0020 affected15 at risk
EG003
Lipase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0012 affected23 at risk
EG0022 affected15 at risk
EG003
Low density lipoprotein increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0012 affected23 at risk
EG0021 affected15 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0004 affected23 at risk
EG0016 affected23 at risk
EG0027 affected15 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0022 affected15 at risk
EG003
Urine output decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Weight decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Abnormal loss of weight
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0007 affected23 at risk
EG0013 affected23 at risk
EG0023 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG003
Feeding disorder
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Poor feeding infant
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Underweight
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0013 affected23 at risk
EG0020 affected15 at risk
EG003
Weight gain poor
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0004 affected23 at risk
EG0012 affected23 at risk
EG0021 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0004 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0003 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0006 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Clonus
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0004 affected23 at risk
EG0012 affected23 at risk
EG0021 affected15 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0008 affected23 at risk
EG0016 affected23 at risk
EG0025 affected15 at risk
EG003
Hypertonia
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Meningism
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Motor developmental delay
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Muscle spasticity
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Seizure
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Adjustment disorder with disturbance of conduct
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0003 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Post-traumatic stress disorder
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG003
Reading disorder
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Genital rash
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0003 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Perineal erythema
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0004 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Adenoidal hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Bronchial wall thickening
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Childhood asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG00014 affected23 at risk
EG00115 affected23 at risk
EG0028 affected15 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Mouth breathing
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG00010 affected23 at risk
EG00110 affected23 at risk
EG0025 affected15 at risk
EG003
Nasal discharge discolouration
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Nasal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG00011 affected23 at risk
EG0015 affected23 at risk
EG0024 affected15 at risk
EG003
Oropharyngeal plaque
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Pharyngeal ulceration
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0015 affected23 at risk
EG0022 affected15 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0007 affected23 at risk
EG0018 affected23 at risk
EG0028 affected15 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0023 affected15 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0004 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Snoring
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Tonsillar inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0022 affected15 at risk
EG003
Use of accessory respiratory muscles
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0013 affected23 at risk
EG0020 affected15 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0012 affected23 at risk
EG0021 affected15 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0014 affected23 at risk
EG0021 affected15 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0013 affected23 at risk
EG0020 affected15 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0013 affected23 at risk
EG0020 affected15 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0012 affected23 at risk
EG0022 affected15 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0003 affected23 at risk
EG0016 affected23 at risk
EG0023 affected15 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0005 affected23 at risk
EG0017 affected23 at risk
EG0026 affected15 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0021 affected15 at risk
EG003
Scab
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0013 affected23 at risk
EG0021 affected15 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0011 affected23 at risk
EG0020 affected15 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 affected23 at risk
EG0013 affected23 at risk
EG0022 affected15 at risk
EG003
Skin plaque
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0002 affected23 at risk
EG0012 affected23 at risk
EG0020 affected15 at risk
EG003
Flushing
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0021 affected15 at risk
EG003
Pallor
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 affected23 at risk
EG0010 affected23 at risk
EG0020 affected15 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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