Trial Outcomes & Findings for Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA) (NCT NCT01513902)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

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

Results posted on

2016-07-04

Participant Flow

Participants aged 2 to less than (\<)18 years with juvenile idiopathic arthritis (JIA) were enrolled in the study.

Participant milestones

Participant milestones
Measure	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.	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).	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).
Overall Study STARTED	8	9	9
Overall Study COMPLETED	8	9	9
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort I: 12 Years to <18 Years n=8 Participants 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.	Cohort II: 6 Years to <12 Years n=9 Participants 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).	Cohort III: 2 Years to <6 Years n=9 Participants 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).	Total n=26 Participants Total of all reporting groups
Age, Continuous	14.1 years STANDARD_DEVIATION 2.0 • n=99 Participants	9.4 years STANDARD_DEVIATION 1.8 • n=107 Participants	4.0 years STANDARD_DEVIATION 1.0 • n=206 Participants	9.0 years STANDARD_DEVIATION 4.5 • n=7 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants	17 Participants n=7 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	4 Participants n=107 Participants	2 Participants n=206 Participants	9 Participants n=7 Participants

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort II: 6 Years to <12 Years n=8 Participants 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).	Cohort III: 2 Years to <6 Years n=9 Participants 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).	Cohort I: 12 Years to <18 Years n=8 Participants 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.
Apparent Oral Clearance (CL/F)	25.48 liter per hour Geometric Coefficient of Variation 40	20.53 liter per hour Geometric Coefficient of Variation 33	28.09 liter per hour Geometric Coefficient of Variation 22

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Cohort II: 6 Years to <12 Years n=9 Participants 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).	Cohort III: 2 Years to <6 Years n=9 Participants 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).	Cohort I: 12 Years to <18 Years n=8 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (AEs) All Causalities SAE	0 participants	0 participants	0 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) All Causalities AE	1 participants	2 participants	1 participants

PRIMARY outcome

Timeframe: Baseline up to Day 5

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

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 \[HPF\]).

Outcome measures

Outcome measures
Measure	Cohort II: 6 Years to <12 Years n=9 Participants 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).	Cohort III: 2 Years to <6 Years n=9 Participants 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).	Cohort I: 12 Years to <18 Years n=8 Participants 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.
Number of Participants With Laboratory Test Abnormalities	1 participants	5 participants	3 participants

PRIMARY outcome

Timeframe: Baseline up to Day 5

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

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.

Outcome measures

Outcome measures
Measure	Cohort II: 6 Years to <12 Years n=9 Participants 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).	Cohort III: 2 Years to <6 Years n=9 Participants 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).	Cohort I: 12 Years to <18 Years n=8 Participants 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.
Number of Participants With Clinically Significant Vital Signs Abnormalities	0 participants	0 participants	0 participants

SECONDARY outcome

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

Population: 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.

Outcome measures

Outcome measures
Measure	Cohort II: 6 Years to <12 Years n=8 Participants 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).	Cohort III: 2 Years to <6 Years n=9 Participants 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).	Cohort I: 12 Years to <18 Years n=8 Participants 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.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	118.8 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 27	142.5 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 32	156.6 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 25

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Cohort II: 6 Years to <12 Years n=9 Participants 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).	Cohort III: 2 Years to <6 Years n=9 Participants 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).	Cohort I: 12 Years to <18 Years n=8 Participants 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.
Maximum Observed Plasma Concentration (Cmax)	41.67 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 29	66.15 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 28	46.97 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 40

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Cohort II: 6 Years to <12 Years n=9 Participants 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).	Cohort III: 2 Years to <6 Years n=9 Participants 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).	Cohort I: 12 Years to <18 Years n=8 Participants 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.
Time to Reach Maximum Observed Plasma Concentration (Tmax)	1.00 hours Full Range 27 • Interval 0.5 to 2.05	0.500 hours Full Range 32 • Interval 0.5 to 1.92	0.750 hours Full Range 25 • Interval 0.5 to 6.9

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort II: 6 Years to <12 Years n=8 Participants 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).	Cohort III: 2 Years to <6 Years n=9 Participants 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).	Cohort I: 12 Years to <18 Years n=7 Participants 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.
Apparent Volume of Distribution (Vz/F)	71.0 liter Geometric Coefficient of Variation 40 • Interval 0.5 to 2.05	51.44 liter Geometric Coefficient of Variation 34 • Interval 0.5 to 1.92	104.9 liter Geometric Coefficient of Variation 35 • Interval 0.5 to 6.9

SECONDARY outcome

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

Population: 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.

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

Outcome measures

Outcome measures
Measure	Cohort II: 6 Years to <12 Years n=8 Participants 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).	Cohort III: 2 Years to <6 Years n=9 Participants 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).	Cohort I: 12 Years to <18 Years n=7 Participants 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.
Plasma Decay Half-Life (t1/2)	1.949 hours Standard Deviation 0.294	1.771 hours Standard Deviation 0.406	2.616 hours Standard Deviation 0.454

SECONDARY outcome

Timeframe: Day 1, Day 5

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

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.

Outcome measures

Outcome measures
Measure	Cohort II: 6 Years to <12 Years n=7 Participants 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).	Cohort III: 2 Years to <6 Years n=9 Participants 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).	Cohort I: 12 Years to <18 Years n=2 Participants 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.
Taste Assessment Day 1: Dislike very much	1 participants 0.29396	1 participants 0.40634	0 participants 0.45350
Taste Assessment Day 1: Dislike a little	0 participants	2 participants	0 participants
Taste Assessment Day 1: Not sure	1 participants	1 participants	1 participants
Taste Assessment Day 1: Like a little	3 participants	1 participants	1 participants
Taste Assessment Day 1: Like very much	2 participants	4 participants	0 participants
Taste Assessment Day 5: Dislike very much	1 participants	0 participants	0 participants
Taste Assessment Day 5: Dislike a little	0 participants	3 participants	1 participants
Taste Assessment Day 5: Not sure	2 participants	1 participants	1 participants
Taste Assessment Day 5: Like a little	2 participants	2 participants	0 participants
Taste Assessment Day 5: Like very much	2 participants	3 participants	0 participants

Adverse Events

Cohort I: 12 Years to <18 Years

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort II: 6 Years to <12 Years

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort III: 2 Years to <6 Years

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort I: 12 Years to <18 Years n=8 participants at risk 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.	Cohort II: 6 Years to <12 Years n=9 participants at risk 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).	Cohort III: 2 Years to <6 Years n=9 participants at risk 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).
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • Baseline up to 28 days after the last dose of study drug (Day 5)	11.1% 1/9 • Baseline up to 28 days after the last dose of study drug (Day 5)	0.00% 0/9 • Baseline up to 28 days after the last dose of study drug (Day 5)
General disorders Fatigue	12.5% 1/8 • Baseline up to 28 days after the last dose of study drug (Day 5)	0.00% 0/9 • Baseline up to 28 days after the last dose of study drug (Day 5)	0.00% 0/9 • Baseline up to 28 days after the last dose of study drug (Day 5)
Infections and infestations Viral infection	0.00% 0/8 • Baseline up to 28 days after the last dose of study drug (Day 5)	0.00% 0/9 • Baseline up to 28 days after the last dose of study drug (Day 5)	11.1% 1/9 • Baseline up to 28 days after the last dose of study drug (Day 5)
Skin and subcutaneous tissue disorders Blister	0.00% 0/8 • Baseline up to 28 days after the last dose of study drug (Day 5)	0.00% 0/9 • Baseline up to 28 days after the last dose of study drug (Day 5)	11.1% 1/9 • Baseline up to 28 days after the last dose of study drug (Day 5)

Additional Information

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Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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