Trial Outcomes & Findings for Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation (NCT NCT03755414)

NCT ID: NCT03755414

Last Updated: 2025-04-06

Results Overview

Failure to engraft will be defined as failure to achieve absolute neutrophil count \>500 for 3 days by day 35.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

55 participants

Primary outcome timeframe

By day 35

Results posted on

2025-04-06

Participant Flow

Participant milestones

Participant milestones
Measure
Pilot Study: Itacitinib
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently * To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
Expansion Phase: Itacitinib
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
Donors
-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.
Overall Study
STARTED
22
27
6
Overall Study
COMPLETED
20
25
4
Overall Study
NOT COMPLETED
2
2
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Pilot Study: Itacitinib
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently * To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
Expansion Phase: Itacitinib
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
Donors
-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.
Overall Study
Did not continue with treatment due to low donor collection
2
1
0
Overall Study
Recipient did not continue with treatment due to low donor cell collection
0
0
2
Overall Study
Non-compliance
0
1
0

Baseline Characteristics

Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pilot Study: Itacitinib
n=22 Participants
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently * To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
Expansion Phase: Itacitinib
n=27 Participants
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
Donors
n=6 Participants
-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.
Total
n=55 Participants
Total of all reporting groups
Age, Continuous
57.5 years
n=5 Participants
61 years
n=7 Participants
37.5 years
n=5 Participants
58 years
n=4 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
9 Participants
n=7 Participants
2 Participants
n=5 Participants
21 Participants
n=4 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
18 Participants
n=7 Participants
4 Participants
n=5 Participants
34 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants
n=5 Participants
27 Participants
n=7 Participants
6 Participants
n=5 Participants
54 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
4 Participants
n=4 Participants
Race (NIH/OMB)
White
18 Participants
n=5 Participants
25 Participants
n=7 Participants
6 Participants
n=5 Participants
49 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Region of Enrollment
United States
22 participants
n=5 Participants
27 participants
n=7 Participants
6 participants
n=5 Participants
55 participants
n=4 Participants

PRIMARY outcome

Timeframe: By day 35

Population: Donors and participants in the Expansion Phase were not evaluable for this outcome measure. There were 2 participants in the Pilot Study who were not evaluable due to not continuing with treatment due to low donor collection.

Failure to engraft will be defined as failure to achieve absolute neutrophil count \>500 for 3 days by day 35.

Outcome measures

Outcome measures
Measure
Pilot Study: Itacitinib
n=20 Participants
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently * To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
Expansion Phase: Itacitinib
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
Donors
-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.
Number of Participants With Graft Failure (Pilot Study Only)
0 Participants

PRIMARY outcome

Timeframe: Through day 100

Population: Donors were not evaluable for this outcome measure. There were 2 participants in the Pilot Study and 2 participants in the Expansion Phase who were not evaluable for this outcome measure.

-Incidence of acute grade III-IV GVHD will be assessed using Mount Sinai Acute GvHD International Consortium (MAGIC) criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).

Outcome measures

Outcome measures
Measure
Pilot Study: Itacitinib
n=20 Participants
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently * To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
Expansion Phase: Itacitinib
n=25 Participants
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
Donors
-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.
Number of Participants With Grades III-IV Acute GVHD
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Through day 28

Population: Donors were not evaluable for this outcome measure. There were 2 participants in the Pilot Study and 2 participants in the Expansion Phase who were not evaluable for this outcome measure.

* The number of participants who experience CRS will be summarized by count of participants who experience Grade 1, 2, 3, 4, \& 5 CRS. The worst grade experienced by participant will be noted. * Grade 1: symptoms not life threatening \& require symptomatic treatment alone, includes fever, nausea, fatigue, malaise * Grade 2: symptoms require/respond to limited intervention - oxygen (O2) \<40%, \<=3 liters (L) nasal cannula or hypotension responsive to fluids or low dose of 1 vasopressor or grade 2 renal or hepatic toxicity * Grade 3: symptoms require/respond to aggressive intervention - O2 \>=40%, \>3L nasal cannula or hypotension requiring high dose or multiple vasopressors or grade 3 renal toxicity or grade 4 transaminitis, new onset altered mental status, new cardiomyopathy without wall motion abnormality * Grade 4: life-threatening symptoms - requirement for ventilator support or grade 4 rental toxicity (excluding transaminitis) * Grade 5: death

Outcome measures

Outcome measures
Measure
Pilot Study: Itacitinib
n=20 Participants
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently * To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
Expansion Phase: Itacitinib
n=25 Participants
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
Donors
-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.
Number of Participants Who Experience Cytokine Release Syndrome (CRS)
Grade 1 or above
18 Participants
15 Participants
Number of Participants Who Experience Cytokine Release Syndrome (CRS)
Grade 2 or above
5 Participants
1 Participants

SECONDARY outcome

Timeframe: Day 180

Population: Donors were not evaluable for this outcome measure. There were 2 participants in the Pilot Study and 2 participants in the Expansion Phase who were not evaluable for this outcome measure.

-Death that results from a transplant procedure-related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause

Outcome measures

Outcome measures
Measure
Pilot Study: Itacitinib
n=20 Participants
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently * To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
Expansion Phase: Itacitinib
n=25 Participants
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
Donors
-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.
Number of Participants With Treatment Related Mortality
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Day 100

Population: Donors and participants in the Pilot Phase are not evaluable for this outcome measure. There were 2 participants in the Expansion Phase who were not evaluable for this outcome measure.

* Incidence of acute grade II-IV GVHD will be assessed using Mount Sinai Acute GvHD International Consortium (MAGIC) criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s). * The cumulative incidence of aGVHD was estimated using Fine-Gray's sub-distribution methods to account for competing risk of death without aGVHD.

Outcome measures

Outcome measures
Measure
Pilot Study: Itacitinib
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently * To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
Expansion Phase: Itacitinib
n=25 Participants
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
Donors
-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.
Cumulative Incidence of Grades II-IV Acute GVHD (Expansion Phase)
20 percent
Interval 7.0 to 38.0

Adverse Events

Pilot Study: Itacitinib

Serious events: 14 serious events
Other events: 20 other events
Deaths: 3 deaths

Expansion Phase: Itacitinib

Serious events: 24 serious events
Other events: 26 other events
Deaths: 8 deaths

Donors

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Pilot Study: Itacitinib
n=20 participants at risk
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently * To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
Expansion Phase: Itacitinib
n=26 participants at risk
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
Donors
-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.
Blood and lymphatic system disorders
Anemia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Blood and lymphatic system disorders
Febrile neutropenia
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
7.7%
2/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Gastrointestinal disorders
Diarrhea
15.0%
3/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Gastrointestinal disorders
Enterocolitis
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Gastrointestinal disorders
Nausea
10.0%
2/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
7.7%
2/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
General disorders
Fever
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
15.4%
4/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
Adenovirus
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
CMV viremia
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
COVID-19 infection
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
Enterococcus bacteremia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
Enterocolitis infectious
10.0%
2/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
11.5%
3/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
HSV stomatitis
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
Lung infection
20.0%
4/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
19.2%
5/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
MSSA bacteremia septic arthritis
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
RSV infection
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
Sepsis
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
7.7%
2/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
Skin infection
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
7.7%
2/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Metabolism and nutrition disorders
Hyperkalemia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Metabolism and nutrition disorders
Hyponatremia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Musculoskeletal and connective tissue disorders
Flank pain
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapsed disease
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
11.5%
3/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Renal and urinary disorders
Acute kidney injury
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
7.7%
2/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Renal and urinary disorders
Cystitis noninfective
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Renal and urinary disorders
Hematuria
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Renal and urinary disorders
Renal colic
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Respiratory, thoracic and mediastinal disorders
Dyspnea
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Respiratory, thoracic and mediastinal disorders
Epistaxis
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.

Other adverse events

Other adverse events
Measure
Pilot Study: Itacitinib
n=20 participants at risk
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently * To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.
Expansion Phase: Itacitinib
n=26 participants at risk
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy * Stem cell transplantation on Day 0 * Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently
Donors
-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.
Blood and lymphatic system disorders
Anemia
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
11.5%
3/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Blood and lymphatic system disorders
Febrile neutropenia
65.0%
13/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
50.0%
13/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Cardiac disorders
Supraventricular tachycardia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Gastrointestinal disorders
Colitis
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Gastrointestinal disorders
Dysphagia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Gastrointestinal disorders
Esophagitis
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Gastrointestinal disorders
Mucositis oral
35.0%
7/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
19.2%
5/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Gastrointestinal disorders
Nausea
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Gastrointestinal disorders
Rectal pain
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Immune system disorders
Cytokine release syndrome
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
BK virus
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
Enterococcus faecium bacteremia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
Enterocolitis infectious
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
Lung infection
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
Paronychia
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
Sepsis
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
7.7%
2/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Infections and infestations
Urinary tract infection
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Investigations
Alanine aminotransferase increased
10.0%
2/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
15.4%
4/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Investigations
Alkaline phosphatase increased
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
7.7%
2/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Investigations
Aspartate aminotransferase increased
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
11.5%
3/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Investigations
Creatinine increased
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Investigations
Electrocardiogram QT corrected interval prolonged
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
7.7%
2/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Investigations
Lymphocyte count decreased
10.0%
2/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
50.0%
13/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Investigations
Neutrophil count decreased
95.0%
19/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
69.2%
18/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Investigations
Platelet count decreased
95.0%
19/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
61.5%
16/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Investigations
Weight loss
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
7.7%
2/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Investigations
White blood cell decreased
100.0%
20/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
65.4%
17/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Metabolism and nutrition disorders
Anorexia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Metabolism and nutrition disorders
Hyperglycemia
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Metabolism and nutrition disorders
Hypernatremia
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Metabolism and nutrition disorders
Hyperphosphatemia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Metabolism and nutrition disorders
Hypertriglyceridemia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
19.2%
5/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Metabolism and nutrition disorders
Hypocalcemia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Metabolism and nutrition disorders
Hypokalemia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
7.7%
2/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Metabolism and nutrition disorders
Hypomagnesemia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
7.7%
2/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Metabolism and nutrition disorders
Hyponatremia
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Nervous system disorders
Encephalopathy
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Nervous system disorders
Headache
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Nervous system disorders
Tremor
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Psychiatric disorders
Insomnia
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
11.5%
3/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Renal and urinary disorders
Acute kidney injury
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Renal and urinary disorders
Renal calculi
5.0%
1/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0.00%
0/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
Vascular disorders
Hypotension
0.00%
0/20 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
3.8%
1/26 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.
0/0 • - Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365).
* SAEs, AEs and all-cause mortality were not collected on donors. * The protocol contains the selected AEs that were collected for those in the pilot and expansion phase. * SAEs and AEs were collected on any patient who received at least one dose of itacitinib. * All-cause morality was collected for any patient who completed were compliant with the assigned treatment.

Additional Information

Dr. Ramzi Abboud

Washington University School of Medicine

Phone: 314-454-8304

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place