Pharmacokinetics Of CP-690,550 In Pediatric Patients With... | NCT01513902

ID	Type	Description	Link
2011-004914-40	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1	Experimental	Ages 12 to less than 18	Drug: CP-690,550
Cohort 2	Experimental	Ages 6 to less than 12	Drug: CP-690,550
Corhort 3	Experimental	Ages 2 to less than 6	Drug: CP-690,550

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CP-690,550	Drug	CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing <40 kg. Oral tablets will be used for children weighing ≥40 kg. Children aged 12 to less than 18 years who are unable to swallow tablets will have the option of taking oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Apparent Oral Clearance (CL/F)	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is also influenced by the fraction of the dose absorbed. Clearance was estimated by non compartmental analysis (NCA) of PK data. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCtau. AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval.	Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) All Causalities	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs included both serious and non-serious AEs.	Baseline up to 28 days after the last dose of study drug (Day 5)
Number of Participants With Laboratory Test Abnormalities	Participants with laboratory test abnormalities of potential clinical concern without regard to baseline abnormality were reported. Criteria: Hematology(hemoglobin,hematocrit,red blood cell[RBC] count:<0.8lower limit of normal [LLN], platelets:<0.5LLN/greater than [>]1.75upper limit of normal[ULN], white blood cell [WBC] count:<0.6LLN></0>1.5ULN, lymphocytes, total neutrophils:<0.8LLN or >1.2ULN, basophils, eosinophil, monocytes:>1.2ULN); Liver Function (total bilirubin: >1.5ULN, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>3.0ULN, total protein, albumin:<0.8LLN or >1.2ULN);Renal Function (blood urea nitrogen, creatinine:>1.3ULN, uric acid:>1.2ULN); Electrolytes (sodium:<0.95LLN or >1.05ULN,potassium,chloride,calcium,bicarbonate:<0.9LLN or >1.1ULN);Clinical chemistry (glucose <0.6LLN or >1.5ULN, creatine kinase:>3.0*ULN); Urinalysis (Urine WBC and RBC: greater than or equal to [>=] 6/High Power Field [HPF]).

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)		Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose
Maximum Observed Plasma Concentration (Cmax)		Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric patients with JIA aged from 2 to less than 18 years with active JIA (extended oligoarthritis, polyarthritis rheumatoid factor positive or negative, psoriatic arthritis, enthesitis related arthritis), in 5 or more joints (using American College Rheumatology definition of active joint) at the time of the first study drug administration.
For subjects receiving MTX treatment, minimum duration of therapy is 4 months and dose stable for at least 6 weeks prior to first dose of study drug. MTX may be administered either orally or parenterally at doses not to exceed 20 mg/wk or 15 mg/m2/week.
A negative QuantiFERON-TB Gold In-Tube test performed within the 3 months prior to screening. A negative PPD test can be substituted for the QuantiFERON-TB Gold In-Tube test only if the central laboratory is unable to perform the test or cannot determine the results to be positive or negative and the Pfizer medical monitor approves it, on a case-by-case basis.

Exclusion Criteria:

Systemic JIA, persistent oligoarthritis, undifferentiated arthritis.
Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease.
History of any other rheumatic autoimmune disease.
Infections:
1. Latent or active TB or any history of previous TB.
2. Chronic infections.
3. Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6 months prior to the first dose of study drug.
4. Any treated infections within 2 weeks of Baseline visit.
5. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
6. History of infected joint prosthesis with prosthesis still in situ.
History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
The biologic agents and DMARDs are disallowed at any time during this study. If a subject needs to be treated with one of these agents, the subject should be discontinued from the study.
Subjects who have been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of study medication or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks following discontinuation of study drug.
Subjects with a malignancy or with a history of malignancy with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Explorer Clinic, University of Minnesota Children's Hospital		Minneapolis	Minnesota	55454	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38298058	Derived	Chang C, Vong C, Wang X, Hazra A, Diehl A, Nicholas T, Mukherjee A. Tofacitinib pharmacokinetics in children and adolescents with juvenile idiopathic arthritis. CPT Pharmacometrics Syst Pharmacol. 2024 Apr;13(4):599-611. doi: 10.1002/psp4.13104. Epub 2024 Jan 31.
29282090	Derived	Ruperto N, Brunner HI, Zuber Z, Tzaribachev N, Kingsbury DJ, Foeldvari I, Horneff G, Smolewska E, Vehe RK, Hazra A, Wang R, Mebus CA, Alvey C, Lamba M, Krishnaswami S, Stock TC, Wang M, Suehiro R, Martini A, Lovell DJ; Pediatric Rheumatology International Trials Organization (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG). Pharmacokinetic and safety profile of tofacitinib in children with polyarticular course juvenile idiopathic arthritis: results of a phase 1, open-label, multicenter study. Pediatr Rheumatol Online J. 2017 Dec 28;15(1):86. doi: 10.1186/s12969-017-0212-y.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
BG001	Cohort II: 6 Years to <12 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
BG002	Cohort III: 2 Years to <6 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0008 BG0019 BG0029 BG00326

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

Apparent Oral Clearance (CL/F)

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is also influenced by the fraction of the dose absorbed. Clearance was estimated by non compartmental analysis (NCA) of PK data. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCtau. AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval.

The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'number of participants analyzed (N)' signifies those participants who were evaluable for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

liter per hour

Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose

ID	Title	Description
OG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
OG001	Cohort II: 6 Years to <12 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
OG002	Cohort III: 2 Years to <6 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).

Units	Counts
Participants	OG0008 OG0018 OG0029

Title

Denominators

Categories

Title	Measurements
	OG00028.09± 22 OG00125.48± 40 OG00220.53± 33

Primary

Number of Participants With Treatment-Emergent Adverse Events (AEs) All Causalities

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs included both serious and non-serious AEs.

The safety analysis population included all participants who received at least 1 dose of study drug.

Posted

Number

participants

Baseline up to 28 days after the last dose of study drug (Day 5)

ID	Title	Description
OG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
OG001	Cohort II: 6 Years to <12 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).

Primary

Number of Participants With Laboratory Test Abnormalities

Participants with laboratory test abnormalities of potential clinical concern without regard to baseline abnormality were reported. Criteria: Hematology(hemoglobin,hematocrit,red blood cell[RBC] count:<0.8*lower limit of normal [LLN], platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal[ULN], white blood cell [WBC] count:<0.6*LLN></0>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function (total bilirubin: >1.5*ULN, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>3.0*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN);Renal Function (blood urea nitrogen, creatinine:>1.3*ULN, uric acid:>1.2*ULN); Electrolytes (sodium:<0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN);Clinical chemistry (glucose <0.6*LLN or >1.5*ULN, creatine kinase:>3.0*ULN); Urinalysis (Urine WBC and RBC: greater than or equal to [>=] 6/High Power Field [HPF]).

The safety analysis population included all participants who received at least 1 dose of study drug.

Posted

Number

participants

Baseline up to Day 5

ID	Title	Description
OG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.

Primary

Number of Participants With Clinically Significant Vital Signs Abnormalities

Criteria for vital signs of potentially clinical concern included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, standing pulse rate of <40 bpm or >140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.

The safety analysis population included all participants who received at least 1 dose of study drug.

Posted

Number

participants

Baseline up to Day 5

ID	Title	Description
OG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
OG001	Cohort II: 6 Years to <12 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).

Secondary

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram*hour per milliliter (ng*hr/mL)

Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose

ID	Title	Description
OG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
OG001	Cohort II: 6 Years to <12 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
OG002	Cohort III: 2 Years to <6 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).

Secondary

Maximum Observed Plasma Concentration (Cmax)

The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram per milliliter (ng/mL)

Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose

ID	Title	Description
OG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
OG001	Cohort II: 6 Years to <12 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
OG002	Cohort III: 2 Years to <6 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax)

The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest.

Posted

Median

Full Range

hours

Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose

ID	Title	Description
OG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
OG001	Cohort II: 6 Years to <12 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
OG002	Cohort III: 2 Years to <6 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).

Secondary

Apparent Volume of Distribution (Vz/F)

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

Posted

Geometric Mean

Geometric Coefficient of Variation

liter

Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose

ID	Title	Description
OG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
OG001	Cohort II: 6 Years to <12 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).

Secondary

Plasma Decay Half-Life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Posted

Mean

Standard Deviation

hours

Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose

ID	Title	Description
OG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
OG001	Cohort II: 6 Years to <12 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
OG002	Cohort III: 2 Years to <6 Years

Secondary

Taste Assessment

Participants were evaluated for taste assessment using a 5 categories questionnaire. Participants were asked to answer one of the following to describe the taste of oral solution of tofacitinib: Dislike very much, dislike a little, not sure, like a little, or like very much. The taste assessment was only performed for participants who received the oral solution. Number of participants within each category are reported.

The analysis population was defined as all participants who had received at least 1 oral solution formulation of tofacitinib.

Posted

Number

participants

Day 1, Day 5

ID	Title	Description
OG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
OG001	Cohort II: 6 Years to <12 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort I: 12 Years to <18 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.	8	1	8
EG001	Cohort II: 6 Years to <12 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).	9	1	9
EG002	Cohort III: 2 Years to <6 Years	CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).	9	2	9

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected8 at risk EG0011 affected9 at risk EG0020 affected9 at risk
Fatigue	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected8 at risk EG0010 affected9 at risk EG0020 affected9 at risk
Viral infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected9 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected8 at risk EG0010 affected9 at risk EG0021 affected9 at risk

ID	Term
D001171	Arthritis, Juvenile
D001168	Arthritis

ID	Term
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