Trial Outcomes & Findings for JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis (NCT NCT02251821)
NCT ID: NCT02251821
Last Updated: 2025-12-04
Results Overview
OS was defined as the time from date of transplantation to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. The 2-year survival probability was estimated using the Kaplan-Meier method and a 2-sided 95% confidence interval (CI).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
2 years
Results posted on
2025-12-04
Participant Flow
The original accrual goal to reach the primary endpoint was 48 patients. An additional 15 patients were added in order to collect samples for our translational work on GVHD biomarkers (total 63). We stopped our accrual at 61 patients when we opened our current study looking giving Rux in the peri-transplant setting.
Participant milestones
| Measure |
Treatment (ruxolitinib, transplant)
Patients receive a ruxolitinib and underwent a myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Methotrexate: Given IV
Mycophenolate Mofetil: Given IV or PO
Ruxolitinib: Given PO
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis
Baseline characteristics by cohort
| Measure |
Treatment (Ruxolitinib, Transplant)
n=61 Participants
Patients receive a ruxolitinib for at least 8 weeks and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.
|
|---|---|
|
DIPSS (Dynamic International Prognostic Scoring System) for Myelofibrosis
Low-risk
|
2 Participants
n=3 Participants
|
|
Karnofsky Performance Status (KPS) at time of HCT
90
|
28 Participants
n=3 Participants
|
|
Karnofsky Performance Status (KPS) at time of HCT
80
|
19 Participants
n=3 Participants
|
|
Karnofsky Performance Status (KPS) at time of HCT
70
|
4 Participants
n=3 Participants
|
|
Age, Continuous
|
57 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
|
Karnofsky Performance Status (KPS) at time of HCT
100
|
10 Participants
n=3 Participants
|
|
DIPSS (Dynamic International Prognostic Scoring System) for Myelofibrosis
Intermediate 1 risk
|
16 Participants
n=3 Participants
|
|
DIPSS (Dynamic International Prognostic Scoring System) for Myelofibrosis
Intermediate 2 risk
|
41 Participants
n=3 Participants
|
|
DIPSS (Dynamic International Prognostic Scoring System) for Myelofibrosis
High-risk
|
2 Participants
n=3 Participants
|
|
Donor Source
HLA-matched sibling
|
25 Participants
n=3 Participants
|
|
Donor Source
Matched unrelated
|
26 Participants
n=3 Participants
|
|
Donor Source
Cord Blood
|
6 Participants
n=3 Participants
|
|
Donor Source
1 allele mismatched unrelated
|
4 Participants
n=3 Participants
|
|
Conditioning Regimen Intensity
High Intensity Myeloablative
|
41 Participants
n=3 Participants
|
|
Conditioning Regimen Intensity
Reduced Intensity Myeloablative
|
20 Participants
n=3 Participants
|
|
Primary or Secondary Myelofibrosis
Primary MF
|
36 Participants
n=3 Participants
|
|
Primary or Secondary Myelofibrosis
Secondary MF
|
25 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOS was defined as the time from date of transplantation to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. The 2-year survival probability was estimated using the Kaplan-Meier method and a 2-sided 95% confidence interval (CI).
Outcome measures
| Measure |
Treatment (ruxolitinib, transplant)
n=61 Participants
Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Methotrexate: Given IV
Mycophenolate Mofetil: Given IV or PO
Ruxolitinib: Given PO
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
2-year Overall Survival (OS) in Patients With Myelofibrosis (MF) Who Receive Treatment With a JAK Inhibitor Followed by an Allogeneic Transplant
|
78.24 percentage of participants
Interval 68.43 to 89.45
|
SECONDARY outcome
Timeframe: Up to 100 days post-transplantPopulation: Only 58 of the 61 patients had acute GVHD scoring completed
Percentage of Participants with Grade II-IV acute GVHD in the first 100 days post HCT.
Outcome measures
| Measure |
Treatment (ruxolitinib, transplant)
n=58 Participants
Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Methotrexate: Given IV
Mycophenolate Mofetil: Given IV or PO
Ruxolitinib: Given PO
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Percentage of Participants With Acute Graft Versus Host Disease (GVHD) Grade II-IV
|
68.97 percent of participants
|
SECONDARY outcome
Timeframe: 2 yearsMax grade of chronic GVHD mild, moderate or severe at any time within the first 2 years following transplant.
Outcome measures
| Measure |
Treatment (ruxolitinib, transplant)
n=61 Participants
Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Methotrexate: Given IV
Mycophenolate Mofetil: Given IV or PO
Ruxolitinib: Given PO
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Percentage of Participants With Chronic Graft Versus Host Disease (GVHD)
|
60.66 percent of participants
|
SECONDARY outcome
Timeframe: 1 yearPatients who had evidence of residual disease by molecular, flow cytometric or cytogenetics/FISH were considered relapsed disease.
Outcome measures
| Measure |
Treatment (ruxolitinib, transplant)
n=61 Participants
Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Methotrexate: Given IV
Mycophenolate Mofetil: Given IV or PO
Ruxolitinib: Given PO
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Percentage of Patients Who Had Relapsed Disease at 1 Year
|
8.29 percent of participants
Interval 3.02 to 17.0
|
SECONDARY outcome
Timeframe: Day 100Patients who died in remission between day of transplant and day 100.
Outcome measures
| Measure |
Treatment (ruxolitinib, transplant)
n=61 Participants
Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Methotrexate: Given IV
Mycophenolate Mofetil: Given IV or PO
Ruxolitinib: Given PO
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Non-relapse Mortality (NRM)
|
4.92 percent of participants
Interval 1.28 to 12.47
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Treatment (ruxolitinib, transplant)
n=61 Participants
Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Methotrexate: Given IV
Mycophenolate Mofetil: Given IV or PO
Ruxolitinib: Given PO
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Non-relapse Mortality (NRM)
|
13.26 percent of participants
Interval 6.15 to 23.15
|
SECONDARY outcome
Timeframe: Up to 42 days post-transplantPatients who failed to achieve ANC \> 500 x 3 or chimerism \> 5% by day 42 post-transplant.
Outcome measures
| Measure |
Treatment (ruxolitinib, transplant)
n=61 Participants
Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Methotrexate: Given IV
Mycophenolate Mofetil: Given IV or PO
Ruxolitinib: Given PO
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Number of Patients Who Experienced Primary Graft Failure/Rejection
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPatients who engrafted with an ANC \>500 x 3 or chimerism \> 5% and then became neutropenic with ANC \<500x3 days or chimerism \<5% without evidence of relapse.
Outcome measures
| Measure |
Treatment (ruxolitinib, transplant)
n=61 Participants
Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Methotrexate: Given IV
Mycophenolate Mofetil: Given IV or PO
Ruxolitinib: Given PO
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Number of Patients Who Experienced Secondary Graft Failure/Poor Graft Function
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 years post-HCTIncludes patients who had a max grade of moderate or severe chronic GVHD by the NIH scoring system at any time between day 0 and 2 years post transplant.
Outcome measures
| Measure |
Treatment (ruxolitinib, transplant)
n=61 Participants
Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Methotrexate: Given IV
Mycophenolate Mofetil: Given IV or PO
Ruxolitinib: Given PO
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Percentage of Patients With a Max Grade of Moderate and Severe Chronic GVHD at Any Time Before 2 Years Post Transplant.
|
44.26 percent of participants
|
SECONDARY outcome
Timeframe: 100 daysPopulation: Only 58 of the 61 patients had acute GVHD scoring completed
Patients who had a max grade of III-IV acute GVHD any time between Day 0 and Day 100.
Outcome measures
| Measure |
Treatment (ruxolitinib, transplant)
n=58 Participants
Patients receive a ruxolitinib and undergo myeloablative or reduced-intensity conditioning followed by transplant and GVHD prophylaxis; see detailed description.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Busulfan: Given IV
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan: Given IV
Methotrexate: Given IV
Mycophenolate Mofetil: Given IV or PO
Ruxolitinib: Given PO
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Percentage of Participants With Acute Graft Versus Host Disease Grade III-IV GVHD
|
17.24 percent of participants
|
Adverse Events
Treatment (ruxolitinib, transplant)
Serious events: 7 serious events
Other events: 61 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Treatment (ruxolitinib, transplant)
n=61 participants at risk
Patients receive a ruxolitinib and underwent a myeloablative or reduced-intensity conditioning followed by transplant and calcineurin inhibitor based GVHD prophylaxis.
|
|---|---|
|
Infections and infestations
Sepsis
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Infections and infestations
Infections Viral
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Renal and urinary disorders
Renal Failure
|
3.3%
2/61 • Number of events 2 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.3%
2/61 • Number of events 2 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse Alveolar Hemorrhage
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
Other adverse events
| Measure |
Treatment (ruxolitinib, transplant)
n=61 participants at risk
Patients receive a ruxolitinib and underwent a myeloablative or reduced-intensity conditioning followed by transplant and calcineurin inhibitor based GVHD prophylaxis.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
44.3%
27/61 • Number of events 27 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Blood and lymphatic system disorders
Hypocellular Marrow
|
4.9%
3/61 • Number of events 3 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Abdominal
|
3.3%
2/61 • Number of events 2 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Hemorrhage
|
6.6%
4/61 • Number of events 4 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Blood and lymphatic system disorders
Thrombocytopenia Grade 4
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Infections and infestations
Infections-Bacterial
|
49.2%
30/61 • Number of events 30 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Infections and infestations
Infections Viral
|
29.5%
18/61 • Number of events 18 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Infections and infestations
Infections Fungal
|
6.6%
4/61 • Number of events 4 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Infections and infestations
Infections Other
|
9.8%
6/61 • Number of events 6 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Cardiac disorders
Elevated Troponin
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Cardiac disorders
Arrythmia
|
6.6%
4/61 • Number of events 4 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Cardiac disorders
tachycardia
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Mucositis
|
63.9%
39/61 • Number of events 39 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Nausea
|
19.7%
12/61 • Number of events 12 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
3/61 • Number of events 3 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Diarrhea
|
6.6%
4/61 • Number of events 4 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Abdominal Distention
|
3.3%
2/61 • Number of events 2 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Anorexia
|
16.4%
10/61 • Number of events 10 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Colitis
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Peritonitis
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Ileus
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Ascites
|
3.3%
2/61 • Number of events 2 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Pneumatosis Intestinalis
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Gastrointestinal disorders
Neutropenic Enterocolitis
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
General disorders
Anasarca
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Hepatobiliary disorders
sinusoidal outlet obstruction
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Hepatobiliary disorders
cholecystitis
|
3.3%
2/61 • Number of events 2 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Hepatobiliary disorders
elevated total bilirubin
|
14.8%
9/61 • Number of events 9 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Hepatobiliary disorders
Elevated ALT
|
9.8%
6/61 • Number of events 6 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Hepatobiliary disorders
Elevated AST
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Investigations
Serum Creatinine Increased
|
3.3%
2/61 • Number of events 2 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.5%
7/61 • Number of events 7 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.9%
3/61 • Number of events 3 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Musculoskeletal and connective tissue disorders
Pain-Lumbosacral
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
6.6%
4/61 • Number of events 4 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Musculoskeletal and connective tissue disorders
Pseudogout
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
9.8%
6/61 • Number of events 6 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Nervous system disorders
Encephalopathy
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Psychiatric disorders
altered mental status
|
4.9%
3/61 • Number of events 3 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Psychiatric disorders
anxiety
|
3.3%
2/61 • Number of events 2 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Psychiatric disorders
psychosis
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Renal and urinary disorders
cystitis-non infectious
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Renal and urinary disorders
viral cystitis
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Renal and urinary disorders
Acute renal failure
|
3.3%
2/61 • Number of events 2 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.8%
6/61 • Number of events 6 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary infiltrate
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Skin and subcutaneous tissue disorders
toxic erythema
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Skin and subcutaneous tissue disorders
rash
|
4.9%
3/61 • Number of events 3 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Skin and subcutaneous tissue disorders
blisters
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Vascular disorders
hypotension
|
3.3%
2/61 • Number of events 2 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Vascular disorders
hypertension
|
4.9%
3/61 • Number of events 3 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Vascular disorders
right atrial thrombus
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Injury, poisoning and procedural complications
ventral hernia
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
|
Endocrine disorders
hemorrhagic pituitary mass
|
1.6%
1/61 • Number of events 1 • Serious AEs and other AEs were assessed for up to 100 days. All-Cause Mortality assessed for up to 5 years.
See attached protocol
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place