Trial Outcomes & Findings for Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer (NCT NCT00089011)
NCT ID: NCT00089011
Last Updated: 2020-01-29
Results Overview
Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
COMPLETED
PHASE2
150 participants
Day 180 post-transplantation
2020-01-29
Participant Flow
Participant milestones
| Measure |
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
|
Arm II (Nonmyeloablative Conditioning With TBI)
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
50
|
|
Overall Study
COMPLETED
|
100
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
n=100 Participants
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
|
Arm II (Nonmyeloablative Conditioning With TBI)
n=50 Participants
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
46 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 180 post-transplantationNumber of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
Outcome measures
| Measure |
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
n=100 Participants
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
|
Arm II (Nonmyeloablative Conditioning With TBI)
n=50 Participants
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Incidence of Grade III/IV GVHD
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 180 post-transplantationNumber of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
Outcome measures
| Measure |
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
n=100 Participants
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
|
Arm II (Nonmyeloablative Conditioning With TBI)
n=50 Participants
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Incidence of Chronic Extensive GVHD
|
15 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 180 post-transplantationNumber of patients who rejected their graft. Rejection is defined as the inability to detect or loss of detection of greater than 5% donor T cells (CD3+) as a proportion of the total T cell population, respectively, after nonmyeloablative HCT.
Outcome measures
| Measure |
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
n=100 Participants
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
|
Arm II (Nonmyeloablative Conditioning With TBI)
n=50 Participants
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Incidences of Graft Rejection
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 1 year after conditioningNumber of patients surviving post-transplant.
Outcome measures
| Measure |
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
n=100 Participants
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
|
Arm II (Nonmyeloablative Conditioning With TBI)
n=50 Participants
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Survival
|
85 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Day 180 post-transplantationNumber of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
Outcome measures
| Measure |
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
n=100 Participants
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
|
Arm II (Nonmyeloablative Conditioning With TBI)
n=50 Participants
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Incidences of Grades II-IV Acute GVHD
|
26 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsRelapse/Progression criteria: CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever \>38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. CMML, AML, ALL \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
Outcome measures
| Measure |
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
n=100 Participants
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
|
Arm II (Nonmyeloablative Conditioning With TBI)
n=50 Participants
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Rates of Disease Progression
|
41 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsNumber of patients who expired with relapsed/progressive disease.
Outcome measures
| Measure |
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
n=100 Participants
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
|
Arm II (Nonmyeloablative Conditioning With TBI)
n=50 Participants
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Rates of Relapse-related Mortality
|
28 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Only those patients who received steroids for treatment of chronic GVHD.
Number of patients that received prednisone treatment of chronic GVHD, and number of days for which they received prednisone.
Outcome measures
| Measure |
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
n=44 Participants
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
|
Arm II (Nonmyeloablative Conditioning With TBI)
n=21 Participants
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Rate and Duration of Steroid Use for the Treatment of Chronic GVHD
|
78 days
Interval 1.0 to 1156.0
|
89 days
Interval 1.0 to 420.0
|
Adverse Events
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
Arm II (Nonmyeloablative Conditioning With TBI)
Serious adverse events
| Measure |
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
n=100 participants at risk
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
|
Arm II (Nonmyeloablative Conditioning With TBI)
n=50 participants at risk
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Cardiac disorders
Death, Renal Failure, Cardiac Failure
|
1.0%
1/100
|
0.00%
0/50
|
|
Immune system disorders
Death due to severe refractory autoimmune hemolytic anemia (present prior to transplant)
|
1.0%
1/100
|
0.00%
0/50
|
|
Hepatobiliary disorders
Death, elevated bilirubin, fevers
|
1.0%
1/100
|
0.00%
0/50
|
|
Eye disorders
Right central artery occlusion with right eye blindness
|
1.0%
1/100
|
0.00%
0/50
|
|
Immune system disorders
Severe abdominal pain due to gut GVHD and supravantricular arrhythmia/Atrial fibrillation
|
1.0%
1/100
|
0.00%
0/50
|
|
Psychiatric disorders
Mental Status Change while on ativan, oxycodone, and flexeril
|
1.0%
1/100
|
0.00%
0/50
|
|
Infections and infestations
Sepsis
|
1.0%
1/100
|
0.00%
0/50
|
|
Hepatobiliary disorders
Elevated LFT's with rising total bilirubin level
|
1.0%
1/100
|
0.00%
0/50
|
|
Vascular disorders
Hypoxia and Hypotension
|
0.00%
0/100
|
2.0%
1/50
|
|
Infections and infestations
Death, secondary to sepsis with multiorgan failure
|
0.00%
0/100
|
2.0%
1/50
|
|
Gastrointestinal disorders
Perforated gastric ulcer
|
0.00%
0/100
|
2.0%
1/50
|
|
Infections and infestations
Death due to adenovirus nephritis, sepsis, multifactorial renal failure
|
0.00%
0/100
|
2.0%
1/50
|
|
Renal and urinary disorders
Elevated creatinine level
|
0.00%
0/100
|
2.0%
1/50
|
Other adverse events
| Measure |
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
n=100 participants at risk
Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0.
fludarabine phosphate: Given IV
total-body irradiation: Undergo radiotherapy
laboratory biomarker analysis: Correlative studies
|
Arm II (Nonmyeloablative Conditioning With TBI)
n=50 participants at risk
Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO.
total-body irradiation: Undergo radiotherapy
mycophenolate mofetil: Given IV or PO
tacrolimus: Given IV or PO
peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Renal and urinary disorders
Increased Creatinine
|
20.0%
20/100
|
30.0%
15/50
|
|
Blood and lymphatic system disorders
Hemolysis / Hemolytic Anemia
|
5.0%
5/100
|
2.0%
1/50
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
8.0%
8/100
|
6.0%
3/50
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia / Hypoxemia
|
5.0%
5/100
|
4.0%
2/50
|
|
Cardiac disorders
Hypotension
|
1.0%
1/100
|
8.0%
4/50
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place