A Clinical Study Of An Investigational Regimen Including... | NCT00040664

Label	Type	Description	Intervention Names
2 to 5 years (FPV/RTV)	Experimental	Two to five years. Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)	Drug: ritonavir Drug: fosamprenavir
6 to 11 years (FPV/RTV)	Experimental	Six to twelve years. Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)	Drug: ritonavir Drug: fosamprenavir
12 to 18 years (FPV/RTV)	Experimental	Twelve to Eighteen years. Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)	Drug: ritonavir Drug: fosamprenavir

Name	Type	Description	Arm Group Labels	Other Names
ritonavir	Drug	ritonavir oral capsules or oral solution	12 to 18 years (FPV/RTV) 2 to 5 years (FPV/RTV) 6 to 11 years (FPV/RTV)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Discontinued Treatment Due to Adverse Events	The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event.	Baseline through end of study (at least Week 168)
Number of Participants With Any Drug-related Grade 2 to 4 Adverse Event	The number of participants with drug-related adverse events coded as Grade 2 (mild), Grade 3 (severe), or Grade 4 (life-threatening).	Baseline through end of study (at least Week 168)
Number of Participants With Grade 3 or 4 Treatment-emergent Laboratory Abnormalities	The number of participants with Grade 3 (severe) or Grade 4 (life-threatening) laboratory abnormalities while on study treatment.	Baseline through end of study (at least Week 168)
Geometric Mean of Steady State Plasma Amprenavir (APV) Parameter: AUC(0-tau)	Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. AUC(0-tau)=area under the concentration curve from time 0 to tau.	0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Geometric Mean of Steady State Plasma APV Parameter: Cmax	Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. Cmax= concentration maximum.	0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4
Median Steady State Plasma APV Tmax

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With HIV-1 RNA <400 Copies Per mL at Weeks 12, 48, 96, and 168 (Time to Loss of Virologic Response [TLOVR] Analysis)	A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies per milliliter (mL) at Weeks 12, 48, 96, and 196. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 12, 48, 96, 168 was determined by the TLOVR algorithm with stratification by the six randomization strata. TLOVR analysis categorizes participants by treatment response. Responders were participants with confirmed viral load <400copies/mL on two consecutive visits.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:
Male or females 2 to 18 years of age
A female is eligible to enter and participate in this study if she is of:
a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial); or,
b. child-bearing potential with a negative serum pregnancy test at screen, a negative urine pregnancy test on Day 1 and who agrees to use one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the product label and the instructions of a physician). Note: hormonal contraceptives are not considered a sufficient form of contraceptive for this study.
Complete abstinence from intercourse from 2 weeks prior to administration of study drugs, throughout the study and for 2 weeks after discontinuation of all study medications. Should a female subject of childbearing potential decide to become sexually active during the course of the study, she must be counselled and be willing to use one of the methods listed below:
Double barrier contraception (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
Any intrauterine device (IUD) with published data showing that the expected failure rate is less than 1% per year (not all IUDs meet this criterion)
Any other method with published data showing that the lowest expected failure rate for that method is less than 1% per year. All subjects participating in this study should be counselled on the practice of safe/safer sex.
Parent or legal guardian (and subject whenever possible) has the ability to understand and provide written informed consent for the subject to participate in the trial. Verbal witnessed assent must be obtained from the subject whenever possible.
Screening plasma HIV-1 RNA > or =400copies/mL.
Subject's who, in the investigator's opinion, and following resistance testing where appropriate, are able to construct an active NRTI backbone regimen consisting of 2 NRTIs.
Subjects must meet one of the following criteria:
ART-naïve subjects are defined as having had < 4 weeks (28 days) therapy with an NRTI, no previous therapy with an NNRTI and < 1 week therapy with an HIV PI.
ART-experienced subjects are defined as having had greater than 4 weeks (28 days) therapy with any NRTI(s) and any length of therapy with any NNRTI(s) and/or a PI. PI-experienced subjects will be eligible if they have previously been treated with < three PIs, excluding AGENERASE. Prior therapy with a RTV boosted PI regimen will be considered as only 1 prior PI as long as the RTV dose was below that recommended for use of RTV as an antiretroviral agent. This specific criterion is not applicable to subjects in screening and/or enrolling after approval of Amendment No. 4. - For subjects screening and/or enrolling after the approval of Amendment No.4, PI naive subjects are defined as ART experienced subjects having less than one week of therapy with a PI and no prior experience with AGENERASE. Prior treatment with NNRTIs and NRTIs is permitted (however, subjects will NOT be permitted to receive concurrent NNRTI therapy while participating in this study)
Exclusion Criteria:
Prior history of having received amprenavir.
Use of non-nucleoside reverse transcriptase inhibitor (NNRTI) therapy within 14 days of study Day 1 or anticipated need for concurrent NNRTI therapy during the study period.
Have had an AIDS defining illness (acute CDC Category C event) within 28 days of screening.
Pregnant or lactating.
Non-nucleoside reverse transcriptase inhibitor therapy within 14 days prior to study drug administration or anticipated need for concurrent NNRTI therapy during the study period.
Subjects who, in the investigator's opinion, are not able to comply with the requirements of the study.
An acute CDC Category C event (per 1993/1994 classification) and/or serious bacterial infection(s) within 28 days prior to study drug administration.
Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the subject unable to take oral medication.
Presence of any serious medical condition (e.g., hemoglobinopathy, chronic anemia,diabetes, cardiac dysfunction and hepatitis) which, in the opinion of the investigator, might compromise the safety of the subject.
Current grade 2 or higher serum lipase within 28 days prior to study drug administration and/or history of clinically relevant pancreatitis within the previous 6 months. - Grade 3 or 4 transaminase levels (ALT and/or AST) within 28 days prior to study drug administration and/or clinically relevant hepatitis within the previous 6 months.
Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days of study drug administration or an anticipated need for such treatment within the study period.
Treatment with immunomodulating agents (e.g., systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (e.g., hydroxyurea or foscarnet) within 28 days of study drug administration.
Treatment with any of the following medications within 28 days prior to receiving study medication or the anticipated need during the study:
Amiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepin, dihydroergotamine, encainide, ergonovine, ergotamine, estazolam, flecainide, flurazepam, lovastatin, meperidine, methylergonovine, midazolam, pimozide, piroxicam, propafenone, propoxyphene, quinidine, rifabutin, simvastatin, terfenadine, triazolam, zolpidem (these drugs have been excluded for safety reasons).
Carbamazepine, dexamethasone, phenobarbital, phenytoin, primidone, rifampin, St Johns Wort (these drugs have been excluded because they have the potential to decrease plasma protease inhibitor concentrations) - Systemic chemotherapeutic agents
Treatment with other investigational drugs/therapies (note: treatments available through a Treatment IND or other expanded-access mechanism will be evaluated on a case-by-case basis in consultation with the sponsor) within 28 days prior to study drug administration
History of drug or other allergy which, in the opinion of the investigator, contraindicates participation in the trial or known hypersensitivity to any study medications (e.g., documented hypersensitivity to a nucleoside analogue).

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35233	United States
GSK Investigational Site

ID	Title	Description
FG000	Overall Fosamprenavir (FPV)/Ritonavir(RTV)	Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
FG001	2-5 Years FPV/RTV

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

Number of Participants Who Discontinued Treatment Due to Adverse Events

The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event.

Safety Population: all participants with documented evidence of having received at least one dose of study drug

Posted

Number

Participants

Baseline through end of study (at least Week 168)

ID	Title	Description
OG000	FPV/RTV	Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)

Units	Counts
Participants	OG00069

Title

Denominators

Categories

Any event

Title	Measurements
	OG00012

Nausea

Title	Measurements
	OG0003

Vomiting

Secondary

Percentage of Participants With HIV-1 RNA <400 Copies Per mL at Weeks 12, 48, 96, and 168 (Time to Loss of Virologic Response [TLOVR] Analysis)

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies per milliliter (mL) at Weeks 12, 48, 96, and 196. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 12, 48, 96, 168 was determined by the TLOVR algorithm with stratification by the six randomization strata. TLOVR analysis categorizes participants by treatment response. Responders were participants with confirmed viral load <400copies/mL on two consecutive visits.

The Intent-to-Treat Exposed (ITT [E]) Population consisted of all subjects with documented evidence of having received at least one dose of study drug. Results are stratified by previous protease inhibitor (PI) experience. Participants with previous PI experience may respond differently to FPV.

Posted

Number

percentage of participants

Weeks 12, 48, 96, and 168

ID	Title	Description
OG000	PI-Naive	Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
OG001	PI-Experienced	Participants treated with equal to or less than 3 PIs (any length of time)

Secondary

Median Change From Baseline HIV-1 RNA Values at Weeks 12, 48, 96, and 168 Visits

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 12, 24, 48, 96, and 168. Change from Baseline was defined as the HIV-1 RNA level at Weeks 12, 24, 48, 96, and 168 minus the HIV-1 RNA level at Baseline.

ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.

Posted

Median

Inter-Quartile Range

log10 copies/mL

Baseline and Weeks 12, 48, 96, and 168

ID	Title	Description
OG000	PI-Naive	Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
OG001	PI-Experienced	Participants treated with equal to or less than 3 PIs (any length of time)

Units	Counts
Participants	OG000

Secondary

Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits

A blood sample was drawn to determine the CD4+ cell count at Weeks 24, 48, 96, and 168. Change from Baseline was defined as the CD4+ cell count at Weeks 24, 48, 96, and 168 minus the CD4+ cell count at Baseline.

ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.

Posted

Median

Inter-Quartile Range

Cells/mm3

Baseline and Weeks 12, 48, 96, and 168

ID	Title	Description
OG000	PI-Naive	Participants with equal to or less than 1 week of treatment with a PI
OG001	PI-Experienced	Participants treated with equal to or less than 3 PIs (any length of time)

Units	Counts
Participants	OG000

Primary

Number of Participants With Any Drug-related Grade 2 to 4 Adverse Event

The number of participants with drug-related adverse events coded as Grade 2 (mild), Grade 3 (severe), or Grade 4 (life-threatening).

Safety Population: all participants with documented evidence of having received at least one dose of study drug

Posted

Number

Participants

Baseline through end of study (at least Week 168)

ID	Title	Description
OG000	FPV Tablet	Fosamprenavir 700 mg tablets/ritonavir 100 mg capsules once daily
OG001	FPV Oral Suspension	Fosamprenavir 50 mg/mL oral suspension/ritonavir 80 mg/mL oral solution once daily

Units	Counts
Participants	OG000

Primary

Number of Participants With Grade 3 or 4 Treatment-emergent Laboratory Abnormalities

The number of participants with Grade 3 (severe) or Grade 4 (life-threatening) laboratory abnormalities while on study treatment.

Safety Population: all participants with documented evidence of having received at least one dose of study drug

Posted

Number

Participants

Baseline through end of study (at least Week 168)

ID	Title	Description
OG000	FPV/RTV	Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)

Units	Counts
Participants	OG000

Primary

Geometric Mean of Steady State Plasma Amprenavir (APV) Parameter: AUC(0-tau)

Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. AUC(0-tau)=area under the concentration curve from time 0 to tau.

The Pharmacokinetic (PK) Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.

Posted

Geometric Mean

95% Confidence Interval

hours*micrograms/milliliter

0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4

ID	Title	Description
OG000	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
OG001	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
OG002	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years

Primary

Geometric Mean of Steady State Plasma APV Parameter: Cmax

The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.

Posted

Geometric Mean

95% Confidence Interval

micrograms/milliliter

0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4

ID	Title	Description
OG000	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
OG001	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
OG002	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
OG003

Secondary

Number of Participants With APV Resistance Associated HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline

A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class. Virologic failure is defined as HIV-1 RNA greater than or equal to 400 copies/mL.

Participants in the ITT-E Population who met the virologic failure definition. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.

Posted

Number

Participants

Time of virologic failure

ID	Title	Description
OG000	PI-Naive	Participants with equal to or less than 1 week of treatment with a PI
OG001	PI-Experienced	Participants treated with equal to or less than 3 PIs (any length of time)

Units	Counts
Participants

Primary

Median Steady State Plasma APV Tmax

tmax: time after administration of the drug when maximum concentration is reached

Posted

Median

Full Range

hours

0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4

ID	Title	Description
OG000	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
OG001	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
OG002	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
OG003	FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years	FPV/RTV 1400/200 mg once daily (tablet), 12-18 years

Primary

Geometric Mean of Steady State Plasma APV Parameter: CL/F

Posted

Geometric Mean

95% Confidence Interval

milliliters/minute/kilogram

0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4

ID	Title	Description
OG000	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
OG001	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
OG002	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data

Primary

Geometric Mean of Steady State Plasma APV Parameter: CL/F

Posted

Geometric Mean

95% Confidence Interval

milliliters/minute

0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4

ID	Title	Description
OG000	FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years	FPV/RTV 1400/200 mg once daily (tablet), 12-18 years

Units	Counts
Participants	OG000

Primary

Geometric Mean of Steady State Plasma APV Parameter: t1/2

Geometric mean is a type of "average" that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. t1/2=elimination half-life. t1/2=elimination half-life.

Posted

Geometric Mean

95% Confidence Interval

hours

0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4

ID	Title	Description
OG000	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
OG001	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
OG002	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years

Primary

Least Squares Mean of Plasma APV Parameter: AUC0-tau

A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.

Posted

Least Squares Mean

95% Confidence Interval

hours*micrograms/milliliters

0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4

ID	Title	Description
OG000	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
OG001	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
OG002

Primary

Least Squares Mean of Plasma APV Parameter: Cmax

Posted

Least Squares Mean

95% Confidence Interval

micrograms/milliliters

0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.

ID	Title	Description
OG000	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
OG001	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
OG002	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years

Primary

Least Squares Mean of Plasma APV Parameter: Ctau

Posted

Least Squares Mean

95% Confidence Interval

microgram per milliliter

0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.

ID	Title	Description
OG000	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
OG001	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years	FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
OG002	FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Drug hypersensitivity	Immune system disorders	MedDRA	Systematic Assessment	EG0003 affected69 at risk
Measles	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected69 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0002 affected69 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Pneumonia bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Aggression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Bipolar disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Borderline personality disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Impulse control disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Anemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Eye penetration	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected69 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00028 affected69 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00018 affected69 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00016 affected69 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected69 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected69 at risk
Dental caries	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected69 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00017 affected69 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG00012 affected69 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00011 affected69 at risk
Otitis media	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected69 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected69 at risk
Oral herpes	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected69 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected69 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected69 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected69 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00016 affected69 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected69 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected69 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected69 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected69 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected69 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00010 affected69 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0004 affected69 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00010 affected69 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00017 affected69 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected69 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0004 affected69 at risk
Conjunctivitis	Eye disorders	MedDRA	Systematic Assessment	EG0004 affected69 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0004 affected69 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds