Trial Outcomes & Findings for Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms (NCT NCT03878199)
NCT ID: NCT03878199
Last Updated: 2026-04-24
Results Overview
DLT occurrence after exposure to ruxolitinib and CPX-351.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Day 1 to day 42
Results posted on
2026-04-24
Participant Flow
Participant milestones
| Measure |
Phase 1 Dose Level 1 (10mg Ruxolitinib)
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Phase 1 Dose Level 2 (20mg Ruxolitinib)
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms
Baseline characteristics by cohort
| Measure |
Dose Level 1 (10mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Dose Level 2 (20mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=2 Participants
|
6 Participants
n=1 Participants
|
9 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=2 Participants
|
5 Participants
n=1 Participants
|
9 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=2 Participants
|
6 Participants
n=1 Participants
|
12 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=2 Participants
|
4 Participants
n=1 Participants
|
10 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=2 Participants
|
6 participants
n=1 Participants
|
12 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Day 1 to day 42DLT occurrence after exposure to ruxolitinib and CPX-351.
Outcome measures
| Measure |
Phase 1 Dose Level 1 (10mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Phase 1 Dose Level 2 (20mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
|---|---|---|
|
Dose Limiting Toxicity (DLT) (Phase I)
Grade 5 Hemorrhagic Stroke
|
1 Participants
|
0 Participants
|
|
Dose Limiting Toxicity (DLT) (Phase I)
Grade 4 Intraparenchymal Hemorrhage
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 to end of induction or re-induction cycle (or upon assessment of the bone marrow biopsy performed near the end of these cycles if this occurs later). Cycle length is 28 days.Will compute the proportion of efficacy-evaluable participants achieving objective response rate (ORR) and the exact binominal 95% confidence interval. The ORR will be calculated as the proportion of participants that achieve at least an Acute Leukemia Response-Partial response (≥ ALR-P, per 2012 MPN-BP criteria).
Outcome measures
| Measure |
Phase 1 Dose Level 1 (10mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Phase 1 Dose Level 2 (20mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
|---|---|---|
|
Proportion of Participants That Achieve at Least an Acute Leukemia Response-Partial Response (>= ALR-P, Per 2012 Myeloproliferative Neoplasm - Blast Phase [MPN-BP] Criteria) (Phase 2)
|
50 percentage of participants
Interval 12.0 to 88.0
|
50 percentage of participants
Interval 12.0 to 88.0
|
SECONDARY outcome
Timeframe: Up to 30 days after last on-study dose, up to 9 months.The number of participants with treatment-related toxicity and the exact confidence interval will be measured. Each toxicity event will be tabulated and summarized by severity and major organ site according to the CTCAE version (v)5.0.
Outcome measures
| Measure |
Phase 1 Dose Level 1 (10mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Phase 1 Dose Level 2 (20mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
|---|---|---|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
ALT Increased-Intermittent (Grade 1-2)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
AST Increased-intermittent (Grade 1-2)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Activated partial thromboplastin time (Grade 1-2)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Alanine aminotransferase increased (Grade 1-2)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Creatinine increased (Grade 1-2)
|
1 participants
|
2 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Dyspnea (Grade 1-2)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Fatigue (Grade 1-2)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Fever (Grade 1-2)
|
1 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Headache (Grade 1-2)
|
1 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Hyperphosphatemia (Grade 1-2)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Hypertriglyceridemia (Grade 1-2)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Intracranial hemorrhage (Grade 1-2)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Mucositis oral ( Grade 1-2)
|
1 participants
|
2 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Nausea (Grade 1-2)
|
3 participants
|
3 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Rash maculo-papular (Grade 1-2)
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Retinopathy (Grade 1-2)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Skin and subcutaneous tissue disorder (Grade 1-2)
|
1 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Upper respiratory infection (Grade 1-2)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Vascular disorders - Other, specify (Grade 1-2)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Vomiting (Grade 1-2)
|
1 participants
|
2 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Bruising (Grade 1-2)
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Diarrhea (Grade 1-2)
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Ejection fraction decreased (Grade 1-2)
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Epistaxis (Grade 1-2)
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
General disorders and administration (Grade 1-2)
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Hypokalemia (Grade 1-2)
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Lymphocyte count decreased (Grade 1-2)
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Sinusitis (Grade 1-2)
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Sore throat ( Grade 1-2)
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Weight gain (Grade 1-2)
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Anemia (Grade 3+)
|
1 participants
|
1 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Febrile neutropenia (Grade 3+)
|
3 participants
|
2 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
General disorders and administration (Grade 3+)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Hematoma (Grade 3)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Lymphocyte count decreased (Grade 3+)
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Nervous system disorders - Other, specify (Grade 3+)
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Neutrophil count decreased (Grade 3+)
|
4 participants
|
2 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Platelet count decreased (Grade 3+)
|
4 participants
|
3 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
White blood cell decreased (Grade 3+)
|
3 participants
|
2 participants
|
|
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Stroke (Grade 3+)
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 4 years.Time-to-event analysis (e.g., Kaplan-Meier curves or cumulative incidence curves) will be used to evaluate overall survival.
Outcome measures
| Measure |
Phase 1 Dose Level 1 (10mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Phase 1 Dose Level 2 (20mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
|---|---|---|
|
Overall Survival (OS)
|
9.3 months
Interval 2.7 to
Insufficient number of participants with events.
|
42.2 months
Interval 0.6 to
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Day 1 to treatment failure, progressive disease, relapse, last exam date, or death (whichever is first), up to 2 yearsTime-to-event analysis (e.g., Kaplan-Meier curves or cumulative incidence curves) will be used to evaluate event-free survival.
Outcome measures
| Measure |
Phase 1 Dose Level 1 (10mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Phase 1 Dose Level 2 (20mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
|---|---|---|
|
Event-free Survival (EFS)
|
1.3 months
Interval 0.7 to
Insufficient number of participants with events
|
1.2 months
Interval 0.5 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Date of first documented response (ALR-C) to date of relapse or death from any cause, up to 2 years.Time-to-event analysis (e.g., Kaplan-Meier curves or cumulative incidence curves) will be used to evaluate relapse-free survival.
Outcome measures
| Measure |
Phase 1 Dose Level 1 (10mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Phase 1 Dose Level 2 (20mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
|---|---|---|
|
Relapse-free Survival (RFS)
|
8.8 months
Interval 8.3 to
Insufficient number of participants with events.
|
3.3 months
Interval 3.3 to
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Date of first documented response (ALR-C) to date of documented relapse, up to 2 yearsTime-to-event analysis (e.g., Kaplan-Meier curves or cumulative incidence curves) will be used to evaluate remission duration.
Outcome measures
| Measure |
Phase 1 Dose Level 1 (10mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Phase 1 Dose Level 2 (20mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
|---|---|---|
|
Remission Duration
|
NA months
Insufficient number of participants with events.
|
NA months
Insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Date of enrollment to time of transplant or end of follow-up (if no transplant), up to 2 yearsA point estimate and 95% confidence interval will be computed for the proportion of participants who undergo an allogeneic (allo)-SCT (stem cell transplant).
Outcome measures
| Measure |
Phase 1 Dose Level 1 (10mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Phase 1 Dose Level 2 (20mg Ruxolitinib)
n=6 Participants
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
|---|---|---|
|
Proportion of Participants Proceeding to Transplant
|
67 percentage of participants
Interval 22.0 to 96.0
|
33 percentage of participants
Interval 4.0 to 78.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to end of induction or re-induction cycle (up to 8 weeks after start of study treatment)Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to end of induction or re-induction cycle (up to 8 weeks after start of study treatment)Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of induction, up to 2 months on studyDetection of MRD will be achieved by either multi-color flow cytometry (MFC) or next-generation sequencing (NGS) technology and examined using regression based analysis (e.g., logistic regression and Cox regression).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of re-induction, up to 4 months on studyDetection of MRD will be achieved by either multi-color flow cytometry (MFC) or next-generation sequencing (NGS) technology and examined using regression based analysis (e.g., logistic regression and Cox regression).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 months on studyDetection of MRD will be achieved by either multi-color flow cytometry (MFC) or next-generation sequencing (NGS) technology and examined using regression based analysis (e.g., logistic regression and Cox regression).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of induction or re-induction, up to 2 months on studyOutcome measures
Outcome data not reported
Adverse Events
Dose Level 1 (10mg Ruxolitinib)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Dose Level 2 (20mg Ruxolitinib)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Level 1 (10mg Ruxolitinib)
n=6 participants at risk
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Dose Level 2 (20mg Ruxolitinib)
n=6 participants at risk
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
|---|---|---|
|
Vascular disorders
Hematoma
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Nervous system disorders
Nervous system disorders - other, intraparenchymal parietal brain bleed (L)
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Injury, poisoning and procedural complications
Postoperative Hemmorhage
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxic respiratory failure
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
Other adverse events
| Measure |
Dose Level 1 (10mg Ruxolitinib)
n=6 participants at risk
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
Dose Level 2 (20mg Ruxolitinib)
n=6 participants at risk
See Detailed Description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Ruxolitinib: Given PO
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Creatinine Increased
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 4 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 5 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
Edema limbs
|
33.3%
2/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
66.7%
4/6 • Number of events 5 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
83.3%
5/6 • Number of events 6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
50.0%
3/6 • Number of events 5 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Fibrinogen decreased
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
Generalized Edema
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
1/6 • Number of events 4 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 4 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Vascular disorders
Hypotension
|
33.3%
2/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
Infusion site extravasation
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
INR (International Normalized Ratio) Increased
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
Leak at PICC site
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
Lesion
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Weight Gain
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Weight loss
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Cardiac disorders
Aortic valve disease
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Cardiac disorders
Atrial Flutter
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Cardiac disorders
Atrioventricular block first degree
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Bone Pain
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
50.0%
3/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
50.0%
3/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
2/6 • Number of events 4 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
50.0%
3/6 • Number of events 5 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Cardiac disorders
Heart failure
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - other, splenomegaly
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
2/6 • Number of events 4 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Laceration
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Lymphocyte count decreased
|
50.0%
3/6 • Number of events 5 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
2/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
50.0%
3/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
66.7%
4/6 • Number of events 10 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Neutrophil count decreased
|
83.3%
5/6 • Number of events 12 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
50.0%
3/6 • Number of events 4 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
Non-neutropenic fever
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Gastrointestinal disorders
Periodontal disease
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Eye disorders
Periorbital edema
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Vascular disorders
Petechia
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Platelet count decreased
|
83.3%
5/6 • Number of events 12 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
50.0%
3/6 • Number of events 4 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Eye disorders
Retinal hemorrhage
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
Ruxolitinib withdrawal syndrome
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - other, scattered ecchymosis
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Sore ankle
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
50.0%
3/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Vascular disorders
Vascular disorders - other, coagulopathy
|
16.7%
1/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
50.0%
3/6 • Number of events 4 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
White blood cell count decreased
|
66.7%
4/6 • Number of events 14 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 5 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Cardiac Troponin I Increased
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Hepatobiliary disorders
chronic liver disease
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Hepatobiliary disorders
gallbladder wall thickening
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
gingival bleeding
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Cardiac disorders
heart rate decreased
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Eye disorders
irritation of left eyelid
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Eye disorders
jaundice (bilateral eyes)
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
jaundice generalized
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
redness at PICC site
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Eye disorders
right subconjunctival hemorrhage
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
General disorders
Scratch
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Soreness at site of biopsy
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
33.3%
2/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Sparse lobular panniculitis
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
spongiotic dermatitis
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Metabolism and nutrition disorders
Steroid-induced hyperglycemia
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Vascular disorders
superficial blood clot
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Swelling
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 3 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Skin and subcutaneous tissue disorders
Swollen Tongue
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 2 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Renal and urinary disorders
Uric Acd Decreased
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
|
Renal and urinary disorders
Volume Overload
|
0.00%
0/6 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
16.7%
1/6 • Number of events 1 • Serious and other, non-serious adverse events were collected for up to 30 days after last on-study dose, up to 9 months. All-cause mortality data was collected from enrollment up to 4 years
|
Additional Information
Dr. Uma Borate
Ohio State University Comprehensive Cancer Center
Phone: 614-685-9828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place