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.
COMPLETED
PHASE1
55 participants
By day 35
2025-04-06
Participant Flow
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
| 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
| 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 35Population: 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
| 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 100Population: 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
| 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 28Population: 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
| 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 180Population: 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
| 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 100Population: 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
| 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
Expansion Phase: Itacitinib
Donors
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place