A Safety Study of VIMOVO in Adolescents With Juvenile Idi... | NCT01544114

NCT01544114

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VIMOVO	Experimental	Three VIMOVO strengths will be used in this study: 250 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 250/20), 375 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 375/20), and 500 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 500/20). The VIMOVO strength allocated to each participant will be determined by the participant's weight at baseline and based on investigator's discretion. The target dose of the naproxen component will be within the range of 10-20 mg/kg/day divided twice daily (BID) with a maximum daily dose of 1000 mg.	Drug: VIMOVO 250/20 Drug: VIMOVO 375/20 Drug: VIMOVO 500/20

Name	Type	Description	Arm Group Labels	Other Names
VIMOVO 250/20	Drug	250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months	VIMOVO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug	An AE is defined as the development of an undesirable medical condition or the deterioration of a preexisting medical condition, whether or not considered causally related to treatment. An SAE is defined as an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. AEs were considered treatment-emergent if they occurred after the first dose of study drug. Events were categorized as mild, moderate, and severe; participants were represented only with the maximum reported intensity.	SAEs were collected from signing of informed consent through Month 6 (or end of treatment) plus 14 days. AEs were collected from administration of VIMOVO through Month 6 (or end of treatment) plus 14 days.

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])		pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Oral Plasma Clearance (CL/F)		pre-dose, and up to 3 hours post-dose

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Little Rock	Arkansas	72202	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29941047	Derived	Lovell DJ, Dare JA, Francis-Sedlak M, Ball J, LaMoreaux BD, Von Scheven E, Reinhardt A, Jerath R, Alpan O, Gupta R, Goldsmith D, Zeft A, Naddaf H, Gottlieb B, Jung L, Holt RJ. A 6-month, multicenter, open-label study of fixed dose naproxen/esomeprazole in adolescent patients with juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2018 Jun 26;16(1):41. doi: 10.1186/s12969-018-0260-y.

Label	URL
Related Info	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	VIMOVO 250 mg/20 mg	250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
FG001	VIMOVO 375 mg/20 mg	375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

naproxen/esomeprazole

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	VIMOVO 250 mg/20 mg	250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
BG001	VIMOVO 375 mg/20 mg	375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
BG002	VIMOVO 500 mg/20 mg	500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0004 BG00120 BG00222 BG00346

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

Title	Measurements
	BG00012.8± 0.96 BG00113.6± 1.47 BG00213.8± 1.33 BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Age Group

Title	Measurements
12 years old	BG0002 BG0017 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0003 BG00115 BG002

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 Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug

An AE is defined as the development of an undesirable medical condition or the deterioration of a preexisting medical condition, whether or not considered causally related to treatment. An SAE is defined as an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. AEs were considered treatment-emergent if they occurred after the first dose of study drug. Events were categorized as mild, moderate, and severe; participants were represented only with the maximum reported intensity.

Safety analysis set: all participants who received at least 1 dose of study drug; participants were categorized according to the treatment medication they actually took.

Posted

Number

participants

SAEs were collected from signing of informed consent through Month 6 (or end of treatment) plus 14 days. AEs were collected from administration of VIMOVO through Month 6 (or end of treatment) plus 14 days.

ID	Title	Description
OG000	VIMOVO 250 mg/20 mg	250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG001	VIMOVO 375 mg/20 mg	375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG002	VIMOVO 500 mg/20 mg	500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG003	Total	250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Units	Counts
Participants	OG0004 OG00120 OG00222 OG003

Title

Denominators

Categories

Any TEAE

Title	Measurements
	OG0004 OG00116 OG00217 OG003

Secondary

Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])

PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.

Posted

Geometric Mean

Geometric Coefficient of Variation

hr*µmol/L

pre-dose, and up to 3 hours post-dose

ID	Title	Description
OG000	VIMOVO 250 mg/20 mg	250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG001	VIMOVO 375 mg/20 mg	375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG002	VIMOVO 500 mg/20 mg	500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG003	Total	250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Secondary

PK of Esomeprazole: Oral Plasma Clearance (CL/F)

Posted

Geometric Mean

Geometric Coefficient of Variation

L/h

pre-dose, and up to 3 hours post-dose

ID	Title	Description
OG000	VIMOVO 250 mg/20 mg	250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG001	VIMOVO 375 mg/20 mg	375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG002	VIMOVO 500 mg/20 mg	500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG003	Total	250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Secondary

PK of Esomeprazole: Absorption Rate Constant (Ka)

Posted

Geometric Mean

Geometric Coefficient of Variation

h^-1

pre-dose, and up to 3 hours post-dose

ID	Title	Description
OG000	VIMOVO 250 mg/20 mg	250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG001	VIMOVO 375 mg/20 mg	375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG002	VIMOVO 500 mg/20 mg	500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG003	Total	250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Secondary

PK of Esomeprazole: Oral Volume of Distribution (V/F)

Posted

Geometric Mean

Geometric Coefficient of Variation

pre-dose, and up to 3 hours post-dose

ID	Title	Description
OG000	VIMOVO 250 mg/20 mg	250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG001	VIMOVO 375 mg/20 mg	375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG002	VIMOVO 500 mg/20 mg	500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG003	Total	250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Secondary

PK of Naproxen: Trough Plasma Concentrations

Trough concentration was defined as lowest plasma concentration from pre-dose to 3 hours post-dose, for each individual participant.

Posted

Geometric Mean

Geometric Coefficient of Variation

µg/mL

Month 1 and Month 3: pre-dose, and up to 3 hours post-dose

ID	Title	Description
OG000	VIMOVO 250 mg/20 mg	250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG001	VIMOVO 375 mg/20 mg	375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
OG002	VIMOVO 500 mg/20 mg	500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	VIMOVO 250 mg/20 mg	250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months	0	4	4	4
EG001	VIMOVO 375 mg/20 mg	375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months	1	20	16	20
EG002	VIMOVO 500 mg/20 mg	500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months	0	22	17	22
EG003	Total	250 mg naproxen/20 mg esomeprazole magnesium, 375 mg naproxen/20 mg esomeprazole magnesium, or 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months	1	46	37	46

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hepatitis Acute	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment		EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG0031 affected46 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0013 affected20 at risk EG0022 affected22 at risk EG0035 affected46 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0012 affected20 at risk EG0022 affected22 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0013 affected20 at risk EG0021 affected22 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0012 affected20 at risk EG0026 affected22 at risk EG003
Sinusitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0024 affected22 at risk EG003
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0023 affected22 at risk EG003
Headache	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected20 at risk EG0022 affected22 at risk EG003
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0012 affected20 at risk EG0020 affected22 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0022 affected22 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0021 affected22 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Mouth Ulceration	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Gastroenteritis Viral	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0022 affected22 at risk EG003
Tooth Infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0021 affected22 at risk EG003
Bacterial Vaginosis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Fungal Infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Helicobacter Infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Influenza	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Localized Infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Otitis Media	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Trichomoniasis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0021 affected22 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Juvenile Idiopathic Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Tendon Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Eye Injury	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Limb Injury	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Arachnoid Cyst	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Dizziness	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Ingrowing Nail	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Breast Mass	Reproductive system and breast disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Menstruation Irregular	Reproductive system and breast disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Ovarian Cyst	Reproductive system and breast disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0010 affected20 at risk EG0020 affected22 at risk EG003
Increased Tendency to Bruise	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Ear Pain	Ear and labyrinth disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Dry Eye	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Uveitis	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Fatigue	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0022 affected22 at risk EG003
Thirst	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0021 affected22 at risk EG003
Liver Function Test Abnormal	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Weight Decreased	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Skin Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0001 affected4 at risk EG0011 affected20 at risk EG0020 affected22 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0011 affected20 at risk EG0021 affected22 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected4 at risk EG0010 affected20 at risk EG0021 affected22 at risk EG003

ID	Term
D001171	Arthritis, Juvenile

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D009288	Naproxen
D064098	Esomeprazole

Ancestor Terms

ID	Term
D009280	Naphthaleneacetic Acids
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring