Trial Outcomes & Findings for GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (NCT NCT03584516)

Last Updated: 2025-10-20

Results Overview

A DLT was defined as the occurrence of any protocol-defined toxicity with onset up to and including Day 28, except those with a clear alternative explanation. Participants who received at least 21 of 28 doses of study drug at the level assigned or had a DLT were considered evaluable for determining tolerability of the dose. Participants who did not achieve this duration of exposure and did not have a DLT were to be replaced for purposes of toxicity identification.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

155 participants

Primary outcome timeframe

up to Day 28

Results posted on

2025-10-20

Participant Flow

This study was conducted at 65 study centers in Austria, Belgium, Canada, Denmark, Germany, Greece, Israel, Italy, Poland, Spain, Switzerland, United Kingdom, and the United States.

Participant milestones

Participant milestones
Measure	Part 1: Itacitinib 200 mg QD + CS Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg QD + CS Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 400 mg QD + CS Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 STARTED	11	10	0	0	0	0
Part 1 COMPLETED	6	5	0	0	0	0
Part 1 NOT COMPLETED	5	5	0	0	0	0
Part 1 Expansion STARTED	0	0	35	39	29	36
Part 1 Expansion COMPLETED	0	0	3	2	1	1
Part 1 Expansion NOT COMPLETED	0	0	32	37	28	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Itacitinib 200 mg QD + CS Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg QD + CS Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 400 mg QD + CS Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 Death	2	3	0	0	0	0
Part 1 Withdrawal by Subject	2	0	0	0	0	0
Part 1 Lost to Follow-up	1	0	0	0	0	0
Part 1 Study Terminated by Sponsor	0	2	0	0	0	0
Part 1 Expansion Death	0	0	9	8	4	5
Part 1 Expansion Lost to Follow-up	0	0	0	1	0	0
Part 1 Expansion Physician Decision	0	0	4	3	2	3
Part 1 Expansion Study Terminated by Sponsor	0	0	17	20	20	23
Part 1 Expansion Withdrawal by Subject	0	0	2	4	2	3
Part 1 Expansion Discontinued Treatment and Terminated CS Tapering	0	0	0	1	0	0
Part 1 Expansion Disease Progression; cGVHD Flare	0	0	0	0	0	1

Baseline Characteristics

GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Itacitinib 200 mg QD + CS n=11 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=10 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg QD + CS n=35 Participants Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 400 mg QD + CS n=39 Participants Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=29 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=36 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Total n=160 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 7.07 • n=5 Participants	58.4 years STANDARD_DEVIATION 15.08 • n=7 Participants	53.6 years STANDARD_DEVIATION 14.01 • n=5 Participants	52.6 years STANDARD_DEVIATION 13.79 • n=4 Participants	52.6 years STANDARD_DEVIATION 12.86 • n=21 Participants	55.7 years STANDARD_DEVIATION 13.32 • n=8 Participants	54.2 years STANDARD_DEVIATION 13.23 • n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	17 Participants n=5 Participants	16 Participants n=4 Participants	14 Participants n=21 Participants	19 Participants n=8 Participants	72 Participants n=8 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants	23 Participants n=4 Participants	15 Participants n=21 Participants	17 Participants n=8 Participants	88 Participants n=8 Participants
Race/Ethnicity, Customized White/Caucasian	11 Participants n=5 Participants	8 Participants n=7 Participants	31 Participants n=5 Participants	36 Participants n=4 Participants	27 Participants n=21 Participants	34 Participants n=8 Participants	147 Participants n=8 Participants
Race/Ethnicity, Customized Black/African-American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	8 Participants n=8 Participants
Race/Ethnicity, Customized Captured as "Other" in Database	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants	26 Participants n=8 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	25 Participants n=5 Participants	26 Participants n=4 Participants	19 Participants n=21 Participants	29 Participants n=8 Participants	113 Participants n=8 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	11 Participants n=8 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants

PRIMARY outcome

Timeframe: up to Day 28

Population: Safety Analysis Set: all enrolled/randomized participants who received at least 1 dose of study drug and/or reference therapy. Treatment groups for this population were determined according to the actual treatment the participant received regardless of assigned study drug treatment.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=11 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=10 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)	0 Participants	1 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: until at least 30 days after the last dose of study treatment (up to 1103 days)

Population: Safety Analysis Set

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=35 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=39 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=29 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=36 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 Expansion: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	34 Participants	38 Participants	28 Participants	32 Participants	—	—	—

PRIMARY outcome

Timeframe: Month 6

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

Response rate was defined as the percentage of participants that had complete response (CR) or partial response (PR), per National Institutes of Health (NIH) Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Months 3 and 6

Population: Safety Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.

Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=35 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=39 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=29 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=36 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 Expansion: Response Rate at Months 3 and 6 Month 3	60.0 percentage of participants Interval 42.1 to 76.1	69.2 percentage of participants Interval 52.4 to 83.0	58.6 percentage of participants Interval 38.9 to 76.5	50.0 percentage of participants Interval 32.9 to 67.1	—	—	—
Part 1 Expansion: Response Rate at Months 3 and 6 Month 6	42.9 percentage of participants Interval 26.3 to 60.6	53.8 percentage of participants Interval 37.2 to 69.9	34.5 percentage of participants Interval 17.9 to 54.3	36.1 percentage of participants Interval 20.8 to 53.8	—	—	—

SECONDARY outcome

Timeframe: Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose

Population: Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and/or reference therapy and provided at least 1 corresponding post-dose plasma sample (1 PK measurement). Because Part I and Part I Expansion were both randomized, open label, and had a parallel design with the same participant population criteria, as pre-specified, the PK data for identical doses/frequency of dosing were grouped for analysis (rather than conducting analysis by treatment arm).

Cmax was defined as the maximum observed concentration of itacitinib.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=3 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=27 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=35 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=26 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS n=3 Participants For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS n=14 Participants Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=16 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Parts 1 and 1 Expansion: Cmax of Itacitinib Day 28	486 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 140	1460 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 67.3	1290 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 248	1350 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 72.2	1350 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 29.4	2040 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 62.6	1580 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 51.4
Parts 1 and 1 Expansion: Cmax of Itacitinib Day 1	201 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation NA SD cannot be reported for a single participant.	655 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 82.9	1050 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 87.3	951 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 68.0	—	769 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 118	736 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 79.1
Parts 1 and 1 Expansion: Cmax of Itacitinib Day 7	191 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation NA SD cannot be reported for a single participant.	1070 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 88.9	1580 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 125	1190 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 103	—	1520 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 73.0	1110 nanomoles per Liter (nmol/L) Geometric Coefficient of Variation 66.2

SECONDARY outcome

Timeframe: Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing)

Population: PK Evaluable Population. Because Part I and Part I Expansion were both randomized, open label, and had a parallel design with the same participant population criteria, as pre-specified, the PK data for identical doses/frequency of dosing were grouped for analysis (rather than conducting analysis by treatment arm).

Ctau was defined as the trough concentration of itacitinib over the dose interval. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=3 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=27 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=35 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=26 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS n=3 Participants For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS n=14 Participants Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=16 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Parts 1 and 1 Expansion: Ctau of Itacitinib Day 1	NA nmol/L Geometric Coefficient of Variation NA The absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Ctau (as more than 3 PK data points are necessary beyond Cmax).	NA nmol/L Geometric Coefficient of Variation NA The absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Ctau (as more than 3 PK data points are necessary beyond Cmax).	0.153 nmol/L Geometric Coefficient of Variation NA The absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Ctau (as more than 3 PK data points are necessary beyond Cmax). Of the total participants analyzed, only 1 participant had a PK profile that allowed for the NCA estimate of the parameter. Thus, the calculation of the SD was not possible.	135 nmol/L Geometric Coefficient of Variation 197	—	7.54 nmol/L Geometric Coefficient of Variation NA The absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Ctau (as more than 3 PK data points are necessary beyond Cmax). Of the total participants analyzed, only 1 participant had a PK profile that allowed for the NCA estimate of the parameter. Thus, the calculation of the SD was not possible.	NA nmol/L Geometric Coefficient of Variation NA The absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Ctau (as more than 3 PK data points are necessary beyond Cmax).
Parts 1 and 1 Expansion: Ctau of Itacitinib Day 7	0.298 nmol/L Geometric Coefficient of Variation NA SD cannot be reported for a single participant.	53.6 nmol/L Geometric Coefficient of Variation 218	52.2 nmol/L Geometric Coefficient of Variation 425	33.5 nmol/L Geometric Coefficient of Variation 118	—	483 nmol/L Geometric Coefficient of Variation 175	127 nmol/L Geometric Coefficient of Variation 177
Parts 1 and 1 Expansion: Ctau of Itacitinib Day 28	10.4 nmol/L Geometric Coefficient of Variation 4440	68.0 nmol/L Geometric Coefficient of Variation 314	42.2 nmol/L Geometric Coefficient of Variation 182	29.7 nmol/L Geometric Coefficient of Variation 152	392 nmol/L Geometric Coefficient of Variation 85.6	460 nmol/L Geometric Coefficient of Variation 123	195 nmol/L Geometric Coefficient of Variation 116

SECONDARY outcome

Timeframe: Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing)

tmax was defined as the time to the maximum concentration of itacitinib. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=3 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=27 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=35 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=26 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS n=3 Participants For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS n=14 Participants Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=16 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Parts 1 and 1 Expansion: Tmax of Itacitinib Day 1	1.0 hours Interval 1.0 to 1.0	2.1 hours Interval 0.9 to 4.8	2.1 hours Interval 0.8 to 5.0	2.0 hours Interval 0.0 to 5.0	—	2.0 hours Interval 1.0 to 5.0	2.4 hours Interval 1.0 to 5.0
Parts 1 and 1 Expansion: Tmax of Itacitinib Day 7	1.0 hours Interval 1.0 to 1.0	2.1 hours Interval 0.0 to 5.0	2.0 hours Interval 1.0 to 13.4	2.0 hours Interval 1.0 to 5.2	—	1.9 hours Interval 0.0 to 10.7	2.0 hours Interval 0.9 to 5.0
Parts 1 and 1 Expansion: Tmax of Itacitinib Day 28	4.0 hours Interval 1.0 to 4.8	3.1 hours Interval 0.8 to 12.0	2.0 hours Interval 0.0 to 16.9	2.1 hours Interval 0.9 to 5.0	2.0 hours Interval 2.0 to 2.2	2.3 hours Interval 2.0 to 5.6	2.0 hours Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing)

Cl/F was defined as the apparent oral dose clearance of itacitinib. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=3 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=27 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=35 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=26 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS n=3 Participants For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS n=14 Participants Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=16 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Parts 1 and 1 Expansion: Cl/F of Itacitinib Day 1	NA Liters per hour Geometric Coefficient of Variation NA The absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Cl/F (as more than 3 PK data points are necessary beyond Cmax).	NA Liters per hour Geometric Coefficient of Variation NA The absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Cl/F (as more than 3 PK data points are necessary beyond Cmax).	258 Liters per hour Geometric Coefficient of Variation NA The absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Cl/F (as more than 3 PK data points are necessary beyond Cmax). Of the total participants analyzed, only 1 participant had a PK profile that allowed for the NCA estimate of the parameter. Thus, the calculation of the SD was not possible.	41.2 Liters per hour Geometric Coefficient of Variation 130	—	640 Liters per hour Geometric Coefficient of Variation NA The absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Cl/F (as more than 3 PK data points are necessary beyond Cmax). Of the total participants analyzed, only 1 participant had a PK profile that allowed for the NCA estimate of the parameter. Thus, the calculation of the SD was not possible.	NA Liters per hour Geometric Coefficient of Variation NA The absence of terminal PK measurements at baseline visits for the timepoint beyond 6 hours did not allow for precise and reasonable NCA estimates related to Cl/F (as more than 3 PK data points are necessary beyond Cmax).
Parts 1 and 1 Expansion: Cl/F of Itacitinib Day 7	224 Liters per hour Geometric Coefficient of Variation NA SD cannot be reported for a single participant.	43.0 Liters per hour Geometric Coefficient of Variation 105	48.9 Liters per hour Geometric Coefficient of Variation 159	85.9 Liters per hour Geometric Coefficient of Variation 90.7	—	31.8 Liters per hour Geometric Coefficient of Variation 82.9	94.4 Liters per hour Geometric Coefficient of Variation 61.3
Parts 1 and 1 Expansion: Cl/F of Itacitinib Day 28	47.7 Liters per hour Geometric Coefficient of Variation 211	30.0 Liters per hour Geometric Coefficient of Variation 96.9	54.8 Liters per hour Geometric Coefficient of Variation 189	81.0 Liters per hour Geometric Coefficient of Variation 65.1	20.2 Liters per hour Geometric Coefficient of Variation 54.2	26.9 Liters per hour Geometric Coefficient of Variation 75.5	67.5 Liters per hour Geometric Coefficient of Variation 62.1

SECONDARY outcome

Timeframe: Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

Cmax was defined as the maximum observed concentration of itacitinib.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

Cmin was defined as the minimum observed plasma or serum concentration of itacitinib over the dose interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

tmax was defined as the time to the maximum concentration of itacitinib.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

AUC0-t was defined as the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

Cl/F was defined as the apparent oral dose clearance of itacitinib.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Months 3, 6, and 12

Population: Safety Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=11 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=10 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1: Response Rate at Months 3, 6, and 12 Month 3	63.6 percentage of participants Interval 30.8 to 89.1	50.0 percentage of participants Interval 18.7 to 81.3	—	—	—	—	—
Part 1: Response Rate at Months 3, 6, and 12 Month 6	36.4 percentage of participants Interval 10.9 to 69.2	50.0 percentage of participants Interval 18.7 to 81.3	—	—	—	—	—
Part 1: Response Rate at Months 3, 6, and 12 Month 12	18.2 percentage of participants Interval 2.3 to 51.8	20.0 percentage of participants Interval 2.5 to 55.6	—	—	—	—	—

SECONDARY outcome

Timeframe: Month 12

Population: Safety Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=35 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=39 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=29 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=36 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 Expansion: Response Rate at Month 12	22.9 percentage of participants Interval 10.4 to 40.1	41.0 percentage of participants Interval 25.6 to 57.9	24.1 percentage of participants Interval 10.3 to 43.5	19.4 percentage of participants Interval 8.2 to 36.0	—	—	—

SECONDARY outcome

Timeframe: up to Month 12

Time to response was defined as the interval between randomization and the first response (CR or PR) before initiation of new therapy. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=31 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=31 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=25 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=26 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 Expansion: Time to Response	16.0 days Interval 12.0 to 120.0	16.0 days Interval 12.0 to 86.0	16.0 days Interval 13.0 to 145.0	16.0 days Interval 13.0 to 88.0	—	—	—

SECONDARY outcome

Timeframe: up to 24 months

Population: Safety Analysis Set. Participants with a first response of CR or PR up to 12 months, until initiation of new anti-GVHD therapy, relapse of underlying malignancy, or overall response of progression or death were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.

Duration to response was defined as the interval between the first response and cGVHD progression, death, or the initiation of a new systemic cGVHD therapy.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=31 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=31 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=25 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=26 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 Expansion: Duration of Response	581.0 days Interval 147.0 to 807.0	NA days Interval 306.0 to The median and the upper limit of the confidence interval were not estimable because too few participants had disease progression or died or initiated new systemic cGVHD therapy.	512.0 days Interval 161.0 to The upper limit of the confidence interval was not estimable because too few participants had disease progression or died or initiated new systemic cGVHD therapy.	197.0 days Interval 103.0 to The upper limit of the confidence interval was not estimable because too few participants had disease progression or died or initiated new systemic cGVHD therapy.	—	—	—

SECONDARY outcome

Timeframe: up to 36 months

Population: Safety Analysis Set. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.

Overall survival was defined as the interval between the date of randomization and the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=35 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=39 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=29 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=36 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 Expansion: Overall Survival	NA days Interval 694.0 to The median and the upper limit of the confidence interval were not estimable because too few participants died.	NA days The median and the upper and lower limits of the confidence interval were not estimable because too few participants died.	NA days The median and the upper and lower limits of the confidence interval were not estimable because too few participants died.	NA days The median and the upper and lower limits of the confidence interval were not estimable because too few participants died.	—	—	—

SECONDARY outcome

Timeframe: up to 24 months

Population: Safety Analysis Set. Participants who did not die due to malignancy relapse were analyzed. The 95% confidence interval was calculated based on the exact method for binomial distributions.

NRM was defined as the percentage of participants who died due to causes other than a relapse of their primary hematologic disease.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=35 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=37 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=28 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=35 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 Expansion: Nonrelapse Mortality (NRM) Rate	25.7 percentage of participants Interval 12.5 to 43.3	15.4 percentage of participants Interval 6.2 to 32.0	10.3 percentage of participants Interval 2.3 to 28.2	11.1 percentage of participants Interval 3.2 to 26.7	—	—	—

SECONDARY outcome

Timeframe: Day 1; Day 180

Population: Safety Analysis Set. Only those participants ongoing in the study at Day 180 were analyzed.

The corticosteroid dose at Day 180 was compared to the corticosteroid dose on Day 1 to assess reduction.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=21 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=27 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=17 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=18 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 Expansion: Percentage of Participants With a ≥50% Reduction in Daily Corticosteroid Dose at Day 180 From the Corticosteroid Dose on Day 1	90.5 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Day 180

Population: Safety Analysis Set. Only those participants ongoing in the study at Day 180 were analyzed.

The percentage of participants who were not taking any corticosteroids at Day 180 was assessed.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=21 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=27 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=17 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=18 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 Expansion: Percentage of Participants Successfully Tapered Off All Corticosteroids at Day 180	52.4 percentage of participants	66.7 percentage of participants	47.1 percentage of participants	44.4 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: up to 1073 days

Population: Safety Analysis Set. The 95% confidence interval was calculated based on the exact method for binomial distributions.

The relapse rate was defined as the percentage of participants whose underlying disease relapsed at any time during the course of the study.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=35 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=39 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=29 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=36 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 Expansion: Relapse Rate of Malignant and Nonmalignant Hematologic Diseases	5.7 percentage of participants Interval 0.7 to 19.2	7.7 percentage of participants Interval 1.6 to 20.9	13.8 percentage of participants Interval 3.9 to 31.7	2.8 percentage of participants Interval 0.1 to 14.5	—	—	—

SECONDARY outcome

Timeframe: up to 24 months

Population: Safety Analysis Set, including censored participants. Censored participants didn't have an event of relapse at any time up to the last assessment date. Participants who didn't have an event of hematologic disease relapse were censored at the time of the last assessment. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method and Klein and Moeschberger's method with log-log transformation.

Time to primary hematologic disease relapse was defined as the interval between the date of randomization and the date of relapse.

Outcome measures

Outcome measures
Measure	Part 1: Itacitinib 200 mg QD + CS n=35 Participants Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=39 Participants Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=29 Participants Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: CS Monotherapy n=36 Participants Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 100 mg BID + CS For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had first or second dose reductions to itacitinib 100 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 200 mg BID + CS Participants were treated with a starting dose of oral itacitinib 300 mg BID + CS in Part 1 Expansion and had their dose decreased to itacitinib 200 mg BID + CS because a boundary was reached during safety run-in or for toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. For toxicity management purposes and/or due to coadministration of strong CYP3A4 inhibitors, participants who received a starting dose of itacitinib 300 mg BID + CS in Part 1 Expansion had a dose reduction to itacitinib 200 mg BID + CS and/or dose interruptions.	Part 1 Expansion: Itacitinib 300 mg BID + CS Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Part 1 Expansion: Time to Primary Hematologic Disease Relapse	NA days Too few participants had an event of relapse for a meaningful median/95% confidence interval to be calculated; thus, the Kaplan-Meier estimator cannot provide a valid estimate.	NA days Too few participants had an event of relapse for a meaningful median/95% confidence interval to be calculated; thus, the Kaplan-Meier estimator cannot provide a valid estimate.	NA days Too few participants had an event of relapse for a meaningful median/95% confidence interval to be calculated; thus, the Kaplan-Meier estimator cannot provide a valid estimate.	NA days Too few participants had an event of relapse for a meaningful median/95% confidence interval to be calculated; thus, the Kaplan-Meier estimator cannot provide a valid estimate.	—	—	—

SECONDARY outcome

Timeframe: Baseline; End of Treatment in Phase 2

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

The LSS consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). It was to be used to assess patient-reported changes in health status, symptoms, and well being.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; End of Treatment in Phase 2

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

The QOL-SF-36 v2 is 36-item scale that captures changes in health status during the course of treatment. The SF-36 assesses 8 health concepts related to limitations in physical activities, social activities, bodily pain, general mental and physical health, and vitality. It was to be used to assess patient-reported changes in health status, symptoms, and well being.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; End of Treatment in Phase 2

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

The EQ-5D-3L is a descriptive classification consisting of 5 dimensions of health: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort. It was to be used to assess patient-reported changes in health status, symptoms, and well being.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; End of Treatment in Phase 2

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

The PGIC is 1 question that captures the overall change in symptoms over the course of treatment. It was to be used to assess patient-reported changes in health status, symptoms, and well being.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; End of Treatment in Phase 2

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

The PGIS is 1 question that captures the overall change in the severity of symptoms over the previous week. It was to be used to assess patient-reported changes in health status, symptoms, and well being.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Months 3 and 12

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

Duration to response was defined as the interval between the first response and cGVHD progression, death, or the initiation of a new systemic cGVHD therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 36 months

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

Overall survival was defined as the interval between the date of randomization and the date of death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

NRM was defined as the percentage of participants who died due to causes other than a relapse of their primary hematologic disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1; Day 180

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

The corticosteroid dose at Day 180 was compared to the corticosteroid dose on Day 1 to assess reduction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 180

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

The percentage of participants who were not taking any corticosteroids at Day 180 was assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

The relapse rate was defined as the defined as the percentage of participants whose underlying disease relapsed at any time during the course of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 24 months

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

Time to primary hematologic disease relapse was defined as the interval between the date of randomization and the date of relapse.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 30 days after the last dose in Phase 2

Population: Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD.

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.

Outcome measures

Outcome data not reported

Adverse Events

Part 1: Itacitinib 200 mg QD + CS

Serious events: 6 serious events

Other events: 11 other events

Deaths: 2 deaths

Part 1: Itacitinib 300 mg QD + CS

Serious events: 5 serious events

Other events: 10 other events

Deaths: 3 deaths

Part 1 Expansion: Itacitinib 300 mg QD + CS

Serious events: 18 serious events

Other events: 33 other events

Deaths: 9 deaths

Part 1 Expansion: Itacitinib 400 mg QD + CS

Serious events: 22 serious events

Other events: 37 other events

Deaths: 8 deaths

Part 1 Expansion: Itacitinib 300 mg BID + CS

Serious events: 12 serious events

Other events: 27 other events

Deaths: 4 deaths

Part 1 Expansion: Total

Serious events: 52 serious events

Other events: 97 other events

Deaths: 21 deaths

Part 1 Expansion: CS Monotherapy

Serious events: 9 serious events

Other events: 31 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Itacitinib 200 mg QD + CS n=11 participants at risk Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=10 participants at risk Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg QD + CS n=35 participants at risk Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 400 mg QD + CS n=39 participants at risk Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=29 participants at risk Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Total n=103 participants at risk Participants received 300 mg QD, 400 mg QD, or 300 mg BID itacitinib plus corticosteroids.	Part 1 Expansion: CS Monotherapy n=36 participants at risk Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Alanine aminotransferase increased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Blood and lymphatic system disorders Anaemia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Appendicitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Aspartate aminotransferase increased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Asthenia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Eye disorders Blindness unilateral	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Blood bilirubin increased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Blood lactic acid increased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Respiratory, thoracic and mediastinal disorders Bronchiolitis obliterans syndrome	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Cardiac disorders Bundle branch block left	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations COVID-19	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.8% 6/103 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations COVID-19 pneumonia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Cardiac disorders Cardiac failure	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Catheter site inflammation	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Cerebral haemorrhage	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Chills	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Clostridial sepsis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Clostridium difficile colitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Colitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Psychiatric disorders Confusional state	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Cystitis viral	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Cytomegalovirus infection	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Cytomegalovirus infection reactivation	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Cytomegalovirus oesophagitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Diarrhoea	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Diverticulitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Renal and urinary disorders Dysuria	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Epilepsy	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Escherichia bacteraemia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Fatigue	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Food intolerance	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Gamma-glutamyltransferase increased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Gastroenteritis Escherichia coli	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Gastroenteritis salmonella	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Renal and urinary disorders Haematuria	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Hepatobiliary disorders Hepatic fibrosis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Herpes zoster cutaneous disseminated	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Vascular disorders Hypotension	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Respiratory, thoracic and mediastinal disorders Hypoxia	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations International normalised ratio increased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Vascular disorders Ischaemic limb pain	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Hepatobiliary disorders Liver injury	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Malaise	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Psychiatric disorders Mental status changes	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Cardiac disorders Myocardial infarction	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Neutropenic sepsis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Oedema	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Oedema peripheral	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Oesophagitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Optic neuritis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Osteonecrosis	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Pancreatitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Parainfluenzae virus infection	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Peritonitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Physical deconditioning	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Platelet count decreased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Pneumonia	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	12.8% 5/39 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.7% 9/103 • Number of events 10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Pneumonia cytomegaloviral	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Pneumonia fungal	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Pneumonia parainfluenzae viral	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Pneumonia streptococcal	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Renal and urinary disorders Pollakiuria	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Progressive multifocal leukoencephalopathy	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Pseudomonal sepsis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Psychiatric disorders Psychiatric decompensation	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Pyrexia	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 4/39 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Eye disorders Retinal vein occlusion	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations SARS-CoV-2 test positive	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Salmonella sepsis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Sepsis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Sinusitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Staphylococcal sepsis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Streptococcal sepsis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Sudden death	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Syncope	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Systemic infection	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Upper respiratory tract infection	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Urinary tract infection	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Urinary tract infection viral	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Vascular disorders Venoocclusive disease	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Vomiting	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.

Other adverse events

Other adverse events
Measure	Part 1: Itacitinib 200 mg QD + CS n=11 participants at risk Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1: Itacitinib 300 mg QD + CS n=10 participants at risk Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg QD + CS n=35 participants at risk Participants were treated with oral itacitinib 300 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 400 mg QD + CS n=39 participants at risk Participants were treated with oral itacitinib 400 mg QD + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Itacitinib 300 mg BID + CS n=29 participants at risk Participants were treated with oral itacitinib 300 mg twice daily (BID) + CS. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). The itacitanib dose could have been decreased to 200 mg BID if a boundary was reached during safety run-in. This treatment group was discontinued due to concern of a potential increase in relapse rate. Participants in this treatment group who were ongoing were allowed to reduce to 400 mg QD plus CS. Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.	Part 1 Expansion: Total n=103 participants at risk Participants received 300 mg QD, 400 mg QD, or 300 mg BID itacitinib plus corticosteroids.	Part 1 Expansion: CS Monotherapy n=36 participants at risk Participants were treated with CS alone. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Abdominal distension	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	4.9% 5/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.8% 7/103 • Number of events 8 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	17.1% 6/35 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.8% 7/103 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Renal and urinary disorders Acute kidney injury	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.0% 2/10 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Alanine aminotransferase increased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	14.3% 5/35 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	15.4% 6/39 • Number of events 14 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.7% 6/29 • Number of events 10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	16.5% 17/103 • Number of events 31 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Skin and subcutaneous tissue disorders Alopecia	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Blood and lymphatic system disorders Anaemia	27.3% 3/11 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.0% 2/10 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	40.0% 14/35 • Number of events 18 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	23.1% 9/39 • Number of events 13 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	34.5% 10/29 • Number of events 12 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	32.0% 33/103 • Number of events 43 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Anal fissure	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Psychiatric disorders Anxiety	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Arthralgia	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 3/29 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.7% 9/103 • Number of events 11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Aspartate aminotransferase increased	18.2% 2/11 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 4/39 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.7% 9/103 • Number of events 15 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Asthenia	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	11.4% 4/35 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.8% 7/103 • Number of events 9 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Cardiac disorders Atrial fibrillation	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	4.9% 5/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.8% 7/103 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Balance disorder	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Eye disorders Blepharitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Blood alkaline phosphatase increased	18.2% 2/11 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Blood bilirubin increased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Blood cholesterol increased	27.3% 3/11 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.0% 2/10 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 4/39 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.8% 4/29 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.7% 11/103 • Number of events 12 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Blood creatinine increased	27.3% 3/11 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.0% 2/10 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 4/39 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 3/29 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	9.7% 10/103 • Number of events 15 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Blood lactate dehydrogenase increased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Blood phosphorus decreased	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Blood potassium decreased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Blood potassium increased	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Blood sodium decreased	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Blood triglycerides increased	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Cardiac disorders Bradycardia	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Reproductive system and breast disorders Breast pain	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Bronchiolitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Bronchitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations COVID-19	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	11.4% 4/35 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	15.4% 6/39 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.8% 4/29 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.6% 14/103 • Number of events 14 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.9% 5/36 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Cardiac disorders Cardiac failure	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Eye disorders Cataract	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Eye disorders Cataract nuclear	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Chest discomfort	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Psychiatric disorders Confusional state	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Conjunctivitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.3% 3/36 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Constipation	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	11.4% 4/35 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	17.9% 7/39 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	12.6% 13/103 • Number of events 13 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Injury, poisoning and procedural complications Contusion	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 4/39 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.8% 6/103 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.3% 3/36 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Endocrine disorders Cushingoid	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Cytomegalovirus infection	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Cytomegalovirus infection reactivation	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.5% 8/39 • Number of events 14 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.8% 4/29 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	14.6% 15/103 • Number of events 25 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.3% 3/36 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Cytomegalovirus test positive	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Cytomegalovirus viraemia	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	12.8% 5/39 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 3/29 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.7% 9/103 • Number of events 10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	11.4% 4/35 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	4.9% 5/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Vascular disorders Deep vein thrombosis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Psychiatric disorders Depression	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Skin and subcutaneous tissue disorders Dermatitis atopic	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Skin and subcutaneous tissue disorders Dermatitis contact	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Device related infection	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Diarrhoea	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	40.0% 4/10 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	17.1% 6/35 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 4/39 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.7% 6/29 • Number of events 9 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	15.5% 16/103 • Number of events 21 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.9% 5/36 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Dizziness	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.8% 7/103 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Drug level increased	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Eye disorders Dry eye	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.8% 6/103 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Dry mouth	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.0% 2/10 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	30.0% 3/10 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	4.9% 5/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Dysgeusia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	4.9% 5/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Dyspepsia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.0% 2/10 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.8% 6/103 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Dysphagia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Respiratory, thoracic and mediastinal disorders Dyspnoea	27.3% 3/11 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	14.3% 5/35 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.8% 8/103 • Number of events 10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.9% 5/36 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 3/29 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	4.9% 5/103 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Epstein-Barr virus infection reactivation	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Injury, poisoning and procedural complications Fall	27.3% 3/11 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.3% 3/36 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Fatigue	36.4% 4/11 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.0% 2/10 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	17.1% 6/35 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	17.9% 7/39 • Number of events 8 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.8% 4/29 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	16.5% 17/103 • Number of events 19 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.9% 5/36 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Blood and lymphatic system disorders Febrile neutropenia	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Flatulence	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Fluid retention	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Gamma-glutamyltransferase increased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 4/39 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.8% 6/103 • Number of events 9 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Renal and urinary disorders Haematuria	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Haemoglobin decreased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.0% 2/10 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Haemoglobin increased	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Blood and lymphatic system disorders Haemolysis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Headache	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.0% 2/10 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	15.4% 6/39 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.7% 9/103 • Number of events 9 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.3% 3/36 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Herpes zoster	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Hordeolum	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Vascular disorders Hot flush	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 3/29 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Hypercholesterolaemia	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	4.9% 5/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Hyperglycaemia	27.3% 3/11 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	11.4% 4/35 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	12.8% 5/39 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.8% 4/29 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	12.6% 13/103 • Number of events 14 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Vascular disorders Hypertension	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.0% 2/10 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	17.1% 6/35 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	17.9% 7/39 • Number of events 8 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	31.0% 9/29 • Number of events 10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	21.4% 22/103 • Number of events 24 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	19.4% 7/36 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Hypertriglyceridaemia	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.5% 8/39 • Number of events 9 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 3/29 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	12.6% 13/103 • Number of events 14 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.3% 3/36 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Hypoaesthesia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	11.4% 4/35 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	4.9% 5/103 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 4/39 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.7% 6/29 • Number of events 8 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	11.7% 12/103 • Number of events 16 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	14.3% 5/35 • Number of events 9 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.8% 8/103 • Number of events 18 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	14.3% 5/35 • Number of events 8 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 3/29 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.7% 11/103 • Number of events 17 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	4.9% 5/103 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Vascular disorders Hypotension	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Endocrine disorders Hypothyroidism	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Influenza like illness	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.5% 8/39 • Number of events 8 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.8% 4/29 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	14.6% 15/103 • Number of events 16 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.9% 5/36 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Eye disorders Lacrimation increased	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Blood and lymphatic system disorders Leukopenia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Injury, poisoning and procedural complications Limb injury	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Liver function test increased	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Lymphocyte count decreased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Vascular disorders Microangiopathy	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	13.8% 4/29 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.8% 6/103 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Muscular weakness	27.3% 3/11 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	40.0% 4/10 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	14.3% 5/35 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 4/39 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.7% 9/103 • Number of events 9 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Skin and subcutaneous tissue disorders Nail ridging	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Nausea	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	22.9% 8/35 • Number of events 10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	12.8% 5/39 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	14.6% 15/103 • Number of events 18 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.3% 3/36 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Neuropathy peripheral	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Blood and lymphatic system disorders Neutropenia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	14.3% 5/35 • Number of events 8 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 3/29 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.7% 11/103 • Number of events 25 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Neutrophil count decreased	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.3% 4/39 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Oedema	9.1% 1/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Oedema peripheral	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	17.1% 6/35 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	12.8% 5/39 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.7% 6/29 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	16.5% 17/103 • Number of events 18 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	16.7% 6/36 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Oral candidiasis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Osteoporosis	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Pain in extremity	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Paraesthesia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Paraesthesia oral	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Parainfluenzae virus infection	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Paronychia	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Platelet count decreased	45.5% 5/11 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	30.0% 3/10 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	17.1% 6/35 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	17.9% 7/39 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	31.0% 9/29 • Number of events 11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	21.4% 22/103 • Number of events 24 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Pneumonia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	4.9% 5/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Pneumonia viral	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Polyneuropathy	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Presyncope	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Respiratory, thoracic and mediastinal disorders Productive cough	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
General disorders Pyrexia	9.1% 1/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	11.4% 4/35 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	12.8% 5/39 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.7% 6/29 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	14.6% 15/103 • Number of events 18 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.3% 3/36 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Skin and subcutaneous tissue disorders Rash	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Renal and urinary disorders Renal failure	18.2% 2/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.0% 2/10 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Respiratory tract infection	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	8.6% 3/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Sciatica	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Immune system disorders Seasonal allergy	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Sinusitis	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Skin infection	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Steroid diabetes	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Cardiac disorders Tachycardia	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	11.4% 4/35 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.8% 6/103 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Blood and lymphatic system disorders Thrombocytopenia	9.1% 1/11 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	20.0% 2/10 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	22.9% 8/35 • Number of events 9 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	17.9% 7/39 • Number of events 8 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	17.2% 5/29 • Number of events 5 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	19.4% 20/103 • Number of events 22 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Injury, poisoning and procedural complications Tooth fracture	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/103 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Nervous system disorders Tremor	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.9% 4/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Upper respiratory tract infection	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Renal and urinary disorders Urinary incontinence	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Urinary tract infection	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	7.7% 3/39 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	4.9% 5/103 • Number of events 7 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Urinary tract infection bacterial	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 4 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	3.4% 1/29 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Infections and infestations Viral upper respiratory tract infection	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.97% 1/103 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Eye disorders Vision blurred	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	6.9% 2/29 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.8% 6/103 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.6% 2/36 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Metabolism and nutrition disorders Vitamin D deficiency	9.1% 1/11 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Gastrointestinal disorders Vomiting	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	11.4% 4/35 • Number of events 6 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.6% 1/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	4.9% 5/103 • Number of events 8 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.8% 1/36 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/35 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Investigations Weight increased	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/10 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 1/35 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.1% 2/39 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	2.9% 3/103 • Number of events 3 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.
Injury, poisoning and procedural complications Wound	0.00% 0/11 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	10.0% 1/10 • Number of events 1 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	5.7% 2/35 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/39 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/29 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	1.9% 2/103 • Number of events 2 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.	0.00% 0/36 • until at least 30 days after the last dose of study treatment (up to 1103 days) Treatment-emergent adverse events (TEAEs), defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug, have been reported. As pre-specified in the SAP, the overall summary of AEs by treatment group included the number of participants with itacitinib dose reductions due to AEs or concomitant strong CYP3A4 inhibitors. The SAP defines "treatment groups" as those to which participants were originally randomized.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Publication restrictions are in place

Restriction type: OTHER